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 Detachment of Device or Device Component (2907)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that a blade detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 6mm x 2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was inflated 16 times, at a maximum of 20 atm, for pre-dilation.The device and all of its components were successfully removed from the body via the usual method.When the device was checked outside of the body, it was noted that a blade had fallen off.The procedure was completed and no patient injury was reported.

Event Description

It was reported that a blade detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 6mm x 2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was inflated 16 times, at a maximum of 20 atm, for pre-dilation.The device and all of its components were successfully removed from the body via the usual method.When the device was checked outside of the body, it was noted that a blade had fallen off.The procedure was completed and no patient injury was reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual, tactile and microscopic examination was performed.Device analysis identified that some damage existed to one of the blade segments.Two of the three blade segments attached to the balloon exhibited no damages.However, the third blade segment was examined and it was noted that approximately 2mm of blade had detached in the proximal end of the blade segment.The detached blade was not received.The pad at the detached section of blade was fully intact and bonded to the balloon.Further analysis of this blade segment noted that the blade and pad were lifted from the balloon at its distal end.No other damage was observed.

• 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: 17347087
• MDR Text Key: 319407658
• Report Number: 2124215-2023-36225
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0031092431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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