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

Model Number 3851

Device Problems Entrapment of Device (1212); Failure to Advance (2524); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was reported that the balloon catheter was stuck on the wire.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon catheter was "glued" on the wire.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

H6 device code: corrected.Device evaluated by manufacturer: the returned product consisted of the wolverine cb mr, ous 10mmx2.00mm.The device was loaded over a guidewire.A visual, tactile, microscopic, device to device interaction test and dimensional testing was performed.Device analysis identified that the inner/wire lumen was stretched down onto the guidewire (which was inserted through the entire wire lumen).As a result of this damage, along with some kinks identified in the distal extrusion, it was not possible to remove the guidewire from the inner/wire lumen.No other damages were observed with the device which could potentially have contributed to the complaint event.

Event Description

It was reported that the balloon catheter was stuck on the wire.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon catheter was "glued" on the wire.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 18635845
• MDR Text Key: 334765275
• Report Number: 2124215-2024-05961
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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: 0032342060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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