Complications Associated With Use of the Wolverine Cutting Balloon: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database
Overall, 2.7% of reported complications were associated with patient injury or death. The most common complication overall was balloon rupture. Device entrapment was the most common complication among reports associated with patient injury or death. Higher inflation pressures and greater number of inflations may be associated with adverse outcomes.
Authors
- Mohammad Ahmed (ORCID: https://orcid.org/0000-0002-5884-7648)
- Ian C. Gilchrist (ORCID: https://orcid.org/0000-0001-8525-8454)
- Jonathan Norton (ORCID: https://orcid.org/0000-0002-2032-3136)
- Chad Zack
- Aaron Lee (ORCID: https://orcid.org/0000-0003-0570-3904)
- Mark Kozak
- Francois P. Kaleta
- Da-Young Jung (ORCID: https://orcid.org/0000-0002-1203-3737)
- Maulin Patel (ORCID: https://orcid.org/0000-0001-7484-073X)
- Samer Muallem
- Moses Mathur (ORCID: https://orcid.org/0000-0003-1159-2411)
Institutions
- Good Samaritan Hospital (US)
- Northwestern Memorial Hospital (US)
- Cook County Health and Hospitals System (US)
- Penn State Milton S. Hershey Medical Center (US)
Publication Details
- Journal
- The Journal of invasive cardiology/The journal of invasive cardiology
- Published
- 2025-01-01
- DOI
- https://doi.org/10.25270/jic/24.00300
- Citations
- 1
- Primary Topic
- Metal Alloys Wear and Properties
- Type
- article
- Field-Weighted Citation Impact
- 0.52