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 Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that the device was difficult to remove from the lesion and procedure was cancelled.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was inflated at 12atm and was then completely deflated.However, it felt like the blade in the distal part was stuck in the calcification and could not be pulled out.After repeating deflation for several times, the device was able to be retrieved from the patient.The procedure was not completed due to this event.No patient complications were reported.

Event Description

It was reported that the device was difficult to remove from the lesion, blade detachment and procedure cancellation occurred.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was inflated at 12atm and was then completely deflated.However, it felt like the blade in the distal part was stuck in the calcification and could not be pulled out.After repeating deflation for several times, the device was able to be retrieved from the patient.The procedure was not completed due to this event.No patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the non tortuous and severely calcified right coronary artery #3.The device was not intact when removed from the patient and perhaps part of the blade was left in the body.No action has been taken on the blades left behind.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).

Event Description

It was reported that the device was difficult to remove from the lesion, blade detachment and procedure cancellation occurred.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was inflated at 12atm and was then completely deflated.However, it felt like the blade in the distal part was stuck in the calcification and could not be pulled out.After repeating deflation for several times, the device was able to be retrieved from the patient.The procedure was not completed due to this event.No patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the non tortuous and severely calcified right coronary artery #3.The device was not intact when removed from the patient and perhaps part of the blade was left in the body.No action has been taken on the blades left behind.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.An examination of the blades noted the following: blade 1 - a blade lift was noted on the proximal balloon segment at the break point.Blade 2 - a blade lift was noted on the proximal balloon segment at the break point.Blade 3 - 1.5 mm portion of blade was missing from the proximal blade segment.All blade pads were intact on the balloon.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11877402
• MDR Text Key: 252420221
• Report Number: 2134265-2021-06674
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026871254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/26/2021; 06/30/2021
• Supplement Dates FDA Received: 06/04/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other