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

Model Number 3852

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

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.The balloon could not be inflated due to a leak in the shaft polymer extrusion of the device.Visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.Visual and microscopic examination observed no damage to the blades.All blades were present and fully bonded to the balloon surface.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be leaking from a shaft longitudinal tear beginning approximately 13mm distal of the guidewire port and extending approximately 2mm distally along the shaft.No other issues were identified during the product analysis.Visual and tactile examination found that the hypotube was kinked at several locations along its length.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 03may2019.It was reported that difficulty inflation of the balloon occurred.A target lesion was located at mid right coronary artery.A 15mmx3.50mm wolverine coronary cutting balloon monorail.During procedure, at inflation, it was noted that the device lost pressure at 2, 4, then 6 atmospheres.Subsequently, they revealed that there was a leak at the shaft transition not at the balloon.The procedure was completed with a non bsc device.No complications reported.However, device analysis revealed aft longitudinal shaft tear.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8640545
• MDR Text Key: 146072085
• Report Number: 2134265-2019-05650
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0022965690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• 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