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 Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Visual and microscopic examination found that the balloon material was torn beneath the blade pad.A v-tear was identified, beginning approximately 4mm distal of the proximal balloon bond and extending longitudinally approximately 4mm distally.The balloon material, blade pad and blade were lifted but the blade was still attached to the blade pad.All blades were present and fully bonded to the balloon material.The type of damage most likely occurred due to interaction with an already placed stent.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands or tip of the device that may have potentially contributed to the complaint incident.A visual and tactile examination found no issues with the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that the device got caught in the stent strut.The target lesion was an area of in-stent restenosis (isr) located in the left main trunk (lmt).A 100mmx3.50mm wolverine coronary cutting balloon was advanced for treatment.However, resistance was felt and the balloon got caught in the stent strut of the 3.5x16 synergy; which was placed a year ago.Subsequently, the blade was found bent when pulled out carefully.The procedure was not completed due to the event.No patient complications were 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9072509
• MDR Text Key: 158710964
• Report Number: 2134265-2019-11202
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0023979019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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
• Treatment: GUIDE CATHETER, HEARTRAIL II 6F BL 4.0 SH; GUIDEWIRE, SION BLUE, RADIFOCUS; IMAGING CATHETER, OPTICROSSHD; INFLATION DEVICE, E-CHARGE 30 INDEFLATOR; STENT, 4.0X9 ULTIMASTER TANSEI
• Patient Age: 84 YR