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 Break (1069); Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 04/08/2021

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.Vascular access was obtained via the left femoral artery.The 80 to 90% stenosed, 48mm x 3.5 mm target lesion was located in the mildly tortuous and moderately calcified right coronary artery.Following predilation with a 3.0x15mm emerge balloon catheter, residual stenosis was 80-85%.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, a non boston scientific guide catheter was advanced to open the radial the femoral artery.The doctor advanced the wolverine balloon and found it difficult and tight to track.The doctor felt there was insufficient stability of the guide catheter, thus switched to a different size of guide catheter.The wolverine was advanced but before the distal tip and the balloon reach the guide catheter, it was noted that the shaft broke at about 5 to 10cm distal part of the wire near the wolverine marker at the end of the wire.The device was removed and the procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon wings were in a deflated state.Contrast media was visible inside the balloon material.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.Damage was noted on the tip of this device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.This device was returned minus its hub.A hypotube break was identified at approximately 122cm proximal to the proximal balloon cone.Multiple hypotube kinks were present along the returned length of hypotube.A visual and tactile examination was completed, and no issues were noted.This device was successfully loaded onto a 0.014 inch guidewire.The device was unable to be loaded through a 6fr guide catheter due to the returned deflated state of the device balloon.

Event Description

It was reported that a shaft break occurred.Vascular access was obtained via the left femoral artery.The 80 to 90% stenosed, 48mm x 3.5 mm target lesion was located in the mildly tortuous and moderately calcified right coronary artery.Following predilation with a 3.0x15mm emerge balloon catheter, residual stenosis was 80-85%.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, a non boston scientific guide catheter was advanced to open the radial the femoral artery.The doctor advanced the wolverine balloon and found it difficult and tight to track.The doctor felt there was insufficient stability of the guide catheter, thus switched to a different size of guide catheter.The wolverine was advanced but before the distal tip and the balloon reach the guide catheter, it was noted that the shaft broke at about 5 to 10cm distal part of the wire near the wolverine marker at the end of the wire.The device was removed and the procedure was completed with another of same device.No patient complications were reported and patient was stable 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: 11745132
• MDR Text Key: 248049652
• Report Number: 2134265-2021-05145
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026144256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON (POST): NC EMERGE 3.75-15; BALLOON (POST): NC EMERGE 3.75-15; BALLOON (PRE): EMERGE 3.0X15 MM; BALLOON (PRE): EMERGE 3.0X15 MM; GUIDE CATHETER: 7FR 3.5 JR MEDTRONIC; GUIDE CATHETER: 7FR 3.5 JR MEDTRONIC; GUIDEWIRE: SAMURAI 0.014 INCH X 190 CM; GUIDEWIRE: SAMURAI 0.014 INCH X 190 CM; GUIDEWIRE: SION BLUE 0.014 INCH+ 160 CM; GUIDEWIRE: SION BLUE 0.014 INCH+ 160 CM; STENT: SYNERGY 3.50X48 MM; STENT: SYNERGY 3.50X48 MM; BALLOON (POST): NC EMERGE 3.75-15; BALLOON (PRE): EMERGE 3.0X15 MM; GUIDE CATHETER: 7FR 3.5 JR MEDTRONIC; GUIDEWIRE: SAMURAI 0.014 INCH X 190 CM; GUIDEWIRE: SION BLUE 0.014 INCH+ 160 CM; STENT: SYNERGY 3.50X48 MM
• Patient Age: 55 YR