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

Model Number 3852

Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported that the balloon catheter was damaged.The target lesion was located in the left anterior descending artery.A 15 mm x 4.00 mm wolverine coronary cutting balloon was selected for use.The device was noted to be damaged.The physician was unable to pass the guidewire through the balloon shaft because the device was "crushed." the procedure was successfully completed with another of same device.No patient complications were reported.

Event Description

It was reported that the balloon catheter was damaged.The target lesion was located in the left anterior descending artery.A 15 mm x 4.00 mm wolverine coronary cutting balloon was selected for use.The device was noted to be damaged.The physician was unable to pass the guidewire through the balloon shaft because the device was "crushed." the procedure was successfully completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon identified no damages.No issues were noted with the hypotube shaft.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the distal extrusion identified that a break occurred in the inner wire lumen at the proximal end of the tip section of the device.The break was inside the balloon.An examination of the break site identified that the inner was stretched down.This type of damage is consistent with excessive force having been applied to the lumen.The tip showed no signs of tip damage.An examination of the markerbands identified that due to the inner lumen being stretched and broken, the proximal markerband is positioned towards the center of the balloon and the distal markerband was free moving along the inner lumen at the site of the break.No damage was observed to the actual markerbands.Device-to-device interaction test was made to load a 0.0140-inch guidewire through the device however due to the distal inner wire lumen being detached and stretched it was not possible.

• 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: 18643898
• MDR Text Key: 334804773
• Report Number: 2124215-2024-03189
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0029957266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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 Race: White