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

Model Number 3855

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/15/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 85% stenosed target lesion was located in the severely calcified proximal to mid left anterior descending artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.The balloon was loaded onto a 300cm non-bsc guidewire but upon advancement, the mid-shaft part of the balloon snapped in half.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that shaft break occurred.The 85% stenosed target lesion was located in the severely calcified proximal to mid left anterior descending artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.The balloon was loaded onto a 300cm non-bsc guidewire but upon advancement, the mid-shaft part of the balloon snapped in half.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The device was returned in two pieces - there was a complete hypotube break present at 43.5 cm distal the end of the strain relief.A visual examination identified that the balloon folds were in a wrapped state and had not been subject to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified a complete break at 43.5 cm distal to the strain relief.Multiple hypotube kinks was also identified.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15538845
• MDR Text Key: 301747362
• Report Number: 2124215-2022-39453
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0029496531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2022
• 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
• Treatment: GUIDEWIRE: 300CM BMW; GUIDEWIRE: 300CM BMW
• Patient Sex: Male