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 Failure to Advance (2524)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile and microscopic examination of the balloon identified a blade lifted on the distal edge of the proximal section of the balloon, the pad was intact.A pinhole was also identified in the mid body of the balloon.Markerbands/tip has no issues were noted with the device that may have potentially contributed to the complaint incident.A visual and tactile examination of the hypotube identified no issues.A visual and tactile examination of shaft polymer extrusion identified that the inner polymer extrusion stretched and kinked distal to the distal markerband.The device was attached to an encore inflation unit and an attempt was made to inflate the balloon for leakage analysis.The device was inflated to rated burst pressure of 12 atmospheres however, a pinhole was noted in the mid body of the balloon.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the device could not cross the lesion.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure it was noted that the device could not cross the lesion.The device was removed using normal method without any problem.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.However, device analysis revealed that the blade lifted on the distal edge of the proximal section of the balloon and a pinhole was also identified in the mid body of the balloon.

• 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: 18035589
• MDR Text Key: 328225185
• Report Number: 2124215-2023-60162
• 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
• Report Date: 10/30/2023

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
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0031949004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 10/30/2023
• 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