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

Model Number 3850

Device Problem Failure to Advance (2524)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 06oct2023.It was reported that the balloon did not cross the lesion.The 90% stenosed target lesion was located in the severely tortuous and calcified right coronary artery (rca).A 6 mm x 3.25 mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon did not cross the diseased segment even after multiple attempts to cross due to severe angulations and stenosis in the anatomy.The procedure was completed with a different balloon.There were no patient complications reported post procedure.However, device analysis revealed that the blade lifted, approximately 1.5mm of a blade segment had detached from its pad.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination of the balloon identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure and was partially inflated with contrast media.A blade was lifted on the proximal side of the balloon.A visual and tactile examination of the hypotube identified no issues.A visual and tactile examination of shaft polymer extrusion identified no issues.No tears were visible in the balloon material.A blade was lifted on the proximal side of the balloon.Approximately 1.5mm of a blade segment had detached from its pad.The pad was intact with no damage noted.No damage was observed to the remaining blades and pads.Marker bands/tip 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 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: 18052431
• MDR Text Key: 327143400
• Report Number: 2124215-2023-57476
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/01/2023

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 Expiration Date: 01/17/2024
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0028690935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: Asian