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 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified no damages of the hypotube shaft profile of shaft polymer extrusion.The device was received with blade protector was covering the blade segments in the balloon.The device was attached to an encore per the instructions for use and a vacuum was applied to the device and the protector was removed with some minor resistance.A microscopic examination of the balloon found that the balloon was twisted (not refolded).It would appear that the balloon was not refolded correctly and the blade protector was just shoved over the balloon.A microscopic examination of the blade segments identified that the distal edge of a proximal blade segment was lifted.No other damage was noted to the other blade segments.No issues identified during examination of the extrusion shaft.A microscopic examination of the tip section found no damage.

Event Description

Reportable based on device analysis completed on 24aug2023.It was reported that the balloon failed to cross the lesion.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified left circumflex artery (lcx).A 10mm x 3.00mm wolverine cutting balloon was selected for use.During the procedure, the cutting balloon could not cross the desired diseased segment in the lcx.The physician used another cutting balloon of the same size and the procedure was successfully completed.No complications were reported.However, device analysis revealed that the distal edge of a proximal blade segment was lifted.

• 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: 17797633
• MDR Text Key: 324013409
• Report Number: 2124215-2023-47281
• 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: 09/22/2023

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: 0029787211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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 Sex: Male
• Patient Weight: 88 KG
• Patient Race: Asian