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

Model Number 3850

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported that blade detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid to proximal left anterior descending artery.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was observed that the blade was about to detach on the balloon when the device was removed.The physician touched the blade and it completely detached.The device was completely removed from the body and the procedure was completed with a different device.As per physician's opinion, the cause of the detachment was due to the severely calcified lesion that makes the device difficult to advance the lesion.There was no patient injury reported.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.An examination of the balloon identified that one of the three blades had detached from the balloon.The detached blade was received in a plastic vile.No damage was observed to the other two blades.An examination of the balloon at the location of the detached blade confirmed that the blade pad was intact.The distal blade tang was still bonded onto the balloon.A microscopic examination of the detached blade segment identified a bend in the blade.This may have resulted after force was applied to the blade resulting in the blade detach.The detached section of blade measured approximately 5mm in length.The proximal blade tang was attached to the detached blade.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.No other issues were identified during the product analysis.

Event Description

It was reported that blade detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid to proximal left anterior descending artery.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was observed that the blade was about to detach on the balloon when the device was removed.The physician touched the blade and it completely detached.The device was completely removed from the body and the procedure was completed with a different device.As per physician's opinion, the cause of the detachment was due to the severely calcified lesion that makes the device difficult to advance the lesion.There was no patient injury 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16664815
• MDR Text Key: 312594515
• Report Number: 2124215-2023-15146
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

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 Expiration Date: 06/07/2024
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0029552481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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