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 Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2020

Event Type  Injury  

Event Description

It was reported that balloon rupture and blade detachment occurred.The procedure was performed to treat in-stent restenosis (isr) of a dialysis maintenance patient.The 75% to 90% stenosed proximal right coronary artery and 90% stenosed distal right coronary artery were severely tortuous and had severe circumferential calcification.Stent malapposition were observed in both lesions, and thrombosis adhesion and neointimal proliferation were observed in a section.A 10mmx3.50mm wolverine coronary cutting balloon was introduced.The distal rca stent was inflated once at 10 atmospheres (atm) and twice at 12 atm.The stent in the proximal rca was inflated once at 20 atm but on the second inflation the balloon ruptured once pressure exceeded 20 atm.The wolverine balloon was removed without any resistance being encountered.Angiography confirmed there was no vessel damage or abnormalities.Intravascular ultrasound (ivus) was performed and a high brightness object with an unusual structure that seemed different from calcification was observed in the vascular lumen.The same area was dilated with a different balloon and ivus confirmed the unusual object had disappeared.The procedure was completed with a different device with no patient injury.The physician thought the blade detachment occurred when excessive force was applied to part of the blade during the application of high balloon pressure at the tortuous area of the isr lesion.

Manufacturer Narrative

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.4 blades were present on the balloon surface however the following blade damage was noted: blade 1: blade segment missing from proximal end to flex point.Pad remained attached and secure to balloon material.Blade 2: blade segment missing from proximal end to flex point.Pad remained attached and secure to balloon material.Blade 03 and 04: no issues noted.A longitudinal tear was noted in the balloon material starting from the distal end of blade 4 and extending through the distal balloon cone, measuring approximately 7mm long.A visual and tactile examination found no issues with the shaft of this device.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

It was reported that a balloon rupture and blade detachment occurred.The procedure was performed to treat in-stent restenosis (isr) of a dialysis maintenance patient.The 75% to 90% stenosed proximal right coronary artery and 90% stenosed distal right coronary artery were severely tortuous and had severe circumferential calcification.Stent malapposition were observed in both lesions, and thrombosis adhesion and neointimal proliferation were observed in a section.A 10mmx3.50mm wolverine coronary cutting balloon was introduced.The distal rca stent was inflated once at 10 atmospheres (atm) and twice at 12 atm.The stent in the proximal rca was inflated once at 20 atm but on the second inflation the balloon ruptured once pressure exceeded 20 atm.The wolverine balloon was removed without any resistance being encountered.Angiography confirmed there was no vessel damage or abnormalities.Intravascular ultrasound (ivus) was performed and a high brightness object with an unusual structure that seemed different from calcification was observed in the vascular lumen.The same area was dilated with a different balloon and ivus confirmed the unusual object had disappeared.The procedure was completed with a different device with no patient injury.The physician thought the blade detachment occurred when excessive force was applied to part of the blade during the application of high balloon pressure at the tortuous area of the isr lesion.

• 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: 10970105
• MDR Text Key: 220413471
• Report Number: 2134265-2020-16573
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025897878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 75