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); Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported that the balloon was difficult to remove.The 95% stenosed target lesion was located in the moderately tortuous proximal to mid-left anterior descending artery.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was difficult to cross the lesion, so the balloon was pushed forcibly.Since it was unable to cross, it was inserted using a non-boston scientific guide extension catheter.It crossed the lesion and dilation was performed, but it got caught in the guide extension catheter during retrieval.It was pulled forcibly and retrieved, but when checked outside the patient's body, the balloon was found to be severely flattened.The blade was gone, so it was checked with ivus.It was confirmed that it was in the lmt, and it was held with the stent.The balloon expanded properly, and the stent was also crimped properly.The physician's comment was that there was resistance when inserting and removing, and it was pushed and pulled strongly, so it seems that the blade came off.The procedure was completed with the original device.No complications were reported and there was no problem with the patient post procedure.

Manufacturer Narrative

The device was returned for analysis.A visual examination identified that the balloon was returned in a flattened deflated state.Solidified media was present inside the balloon material.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface and the following blade damage was noted.On blade 1, a 1mm portion of the blade segment was found to be missing.T-slots of the blade were still present, set into the balloon pad.The pad was found to be secured to the balloon surface.On blade 2, a 2mm portion of the blade at the proximal balloon end was found to be lifted and raised from the balloon pad.The tang of the blade remained secured into the pad.The pad was found to be secured onto the balloon surface.On blade 3, no issues were noted.A visual and tactile examination of the shaft found multiple hypotube kinks.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 the balloon was difficult to remove.The 95% stenosed target lesion was located in the moderately tortuous proximal to mid-left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was difficult to cross the lesion, so the balloon was pushed forcibly.Since it was unable to cross, so it was inserted using non-bsc guide extension catheter.Then, it crossed the lesion and dilation was performed, but it got caught in the non-bsc guide extension catheter during retrieval.It was pulled forcibly and retrieved, but when checked outside the patient's body, the balloon was found to be severely flattened.The blade was gone, so it was checked with ivus.It was confirmed that it was in the lmt, and it was held with stent.The balloon expanded properly, and the stent also crimped properly.The physician's comment was that there was resistance when inserting and removing, and it was pushed and pulled strongly, so it seems that the blade came off.The procedure was completed with the original device.No complications were reported and there was no problem with the patient post procedure.

• 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: 10627179
• MDR Text Key: 209806444
• Report Number: 2134265-2020-13369
• 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
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025262603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE EXTENSION CATHETER - GUIDE LINER; GUIDE EXTENSION CATHETER - GUIDE LINER; GUIDE EXTENSION CATHETER - GUIDE LINER
• Patient Outcome(s): Other