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

Model Number	3854
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon burst at rated burst pressure.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual, tactile, microscopic and leakage testing was performed.A visual examination of the device identified a large build-up of solidified blood inside the balloon and inflation lumen.This blood is indicative of a leak having occurred in the device.A detailed microscopic examination of the balloon and inflation lumen identified no tears or holes.Several failed attempts were made to inflate the balloon.Further analysis of the distal extrusion identified that the distal extrusion was stretched at various locations along its length.As a result of this stretching, it was not possible to inflate liquid into the balloon in order to confirm if a leak was present.
Event or Problem Description
It was reported that a balloon rupture occurred.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon burst at rated burst pressure.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications reported.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17871000
• Report Number: 2124215-2023-54846
• Device Sequence Number: 12250612
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2024
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0029778821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2022
• 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
• Patient Sex: Unknown