MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3854

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: the information was not provided, however the date of event was populated as the first day of the month from the bsc aware date.Device evaluated by manufacturer: the device was returned for analysis.An examination of the tip identified a break in the wire lumen inside the balloon.This break occurred at the proximal edge of the distal balloon sleeve.As a result of the break the inner/wire lumen was pulled proximally inside the balloon resulting in a gap of 8mm between the break site at the distal sleeve and the separated inner inside the balloon.This resulted in both markerbands being miss-positioned inside the balloon.As a result of this break, the recommended 0.014 inch wire could not be inserted through the wire lumen.The break site appeared stretched, consistent with excessive tensile force having been applied to the shaft.The markerbands were fully attached to the inner extrusion.However, as a result of the break in the inner the markerbands were miss-positioned with respect to the balloon.No damage was observed with the markerbands or inner extrusion.All blades were present and fully bonded to the surface of the balloon.No issues were noted that may have potentially contributed to the complaint incident.Microscopic analysis identified that the balloon was tightly folded and showed no signs of having been inflated.No issues were identified with the balloon material that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 15aug2019.It was reported that the device has difficulty track over wire occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During preparation, it was noted that the device was unable to load the wire through the end of the balloon.No complications were reported.The patient condition was ok.However, device analysis revealed a break in the wire lumen inside the balloon.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• 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 Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8976118
• MDR Text Key: 156947102
• Report Number: 2134265-2019-10676
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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