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 Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that the balloon leaked.A 70-90% stenosed target lesion was located in the severely calcified artery.A 15 mm x 4.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that there was a leak in the balloon.The balloon was removed over the guidewire wire and a pinhole was noted.The procedure was completed using an additional wolverine.No complications were reported.

Event Description

It was reported that the balloon leaked.A 70-90% stenosed target lesion was located in the severely calcified artery.A 15 mm x 4.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that there was a leak in the balloon.The balloon was removed over the guidewire wire and a pinhole was noted.The procedure was completed using an additional wolverine.No complications were reported.It was further reported that 6 atm of pressure was applied to the balloon and inflation failed to occur.

Event Description

It was reported that the balloon leaked.A 70-90% stenosed target lesion was located in the severely calcified artery.A 15 mm x 4.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that there was a leak in the balloon.The balloon was removed over the guidewire wire and a pinhole was noted.The procedure was completed using an additional wolverine.No complications were reported.It was further reported that 6 atm of pressure was applied to the balloon and inflation failed to occur.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual/tactile inspection, microscopic analysis and functional testing were performed.A detailed microscopic examination of the balloon material identified a pinhole tear 2mm proximal to the proximal markerband.An attempt was then made to inflate the balloon to 12 atmospheres as per wolverine instructions for use using the inflation aid, however, a leak was noted coming from the pinhole proximal to the proximal markerband.No other device issues were identified during returned product analysis.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18904046
• MDR Text Key: 337664246
• Report Number: 2124215-2024-15532
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 05/06/2024

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: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0032470133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 04/17/2024
• Supplement Dates FDA Received: 04/08/2024; 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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