MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	H74939401102750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Shockwave lithoplasty compared to cutting balloon treatment in calcified coronary disease: a randomized controlled trial (short-cut trial).It was reported that cardiac perforation occurred.On (b)(6) 2024, the subject presented with stable angina and underwent percutaneous coronary intervention (pci) using cutting balloon angioplasty in the mid left descending coronary artery (lad).Pre-procedure timi flow was i with 99% stenosis.A 10mmx2.75mm wolverine cutting balloon was selected for procedure.During procedure, drug eluting stent was implanted in the mid lad followed by post-stent dilation with a non-complaint balloon.A small cardiac perforation of the mid lad was noted and was treated with a covered stent and protamine.Post procedure timi flow was iii with 0% stenosis.The patient was discharged the same day.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21036718
• Report Number: 2124215-2024-82001
• Device Sequence Number: 7631194
• Product Code: NWX
• UDI-Device Identifier: 08714729888253
• UDI-Public: 08714729888253
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2026
• Device Model Number: H74939401102750
• Device Catalogue Number: H74939401102750
• Device Lot Number: 0034039090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/30/2024
• Date Device Manufactured: 05/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male