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

Model Number 3851

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a tight lesion and initially inflated at several (atm) and several seconds.However, the device ruptured like a pinhole shape.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr:the returned device was visually and microscopically inspected for damage.The device was attached to an encore inflation unit and inflated to rbp where a leak was observed from the pinhole tear near the proximal markerband.A detailed microscopic examination of the balloon material identified a pinhole leak, 2mm distal to the proximal markerband.An attempt was then made to inflate the balloon to 12 atmospheres using the inflation aid, however, a leak was noted coming from the pinhole tear near the proximal markerband.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint of balloon material rupture was confirmed.

Event Description

It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a tight lesion and initially inflated at several (atm) and several seconds.However, the device ruptured like a pinhole shape.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: 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: 18395177
• MDR Text Key: 331541952
• Report Number: 2124215-2023-73780
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0031954205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1