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

Model Number 3852

Device Problem Material Rupture (1546)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

It was reported that the balloon ruptured.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another of the same device.There was no patient injury.

Event Description

It was reported that the balloon ruptured.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The procedure was completed with another of the same device.There was no patient injury.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual examination of the balloon found no tears or holes in the balloon material.An attempt was made to inflate the balloon which failed.The failure to inflate was consistent with the large build-up of solidified media present inside the balloon.The device was soaked in a water bath at 37 degrees celsius in order to soften the solidified media.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located at the mid-body of the balloon.A microscopic examination of the balloon material and markerband identified no issues which could potentially have contributed to the pinhole leak.No damage was observed to any of the blades.All blades are fully bonded onto the balloon.A visual and tactile examination found no issues with the hypotube of this device.The markerbands and tip and 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.No other issues were identified during the product analysis.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13076243
• MDR Text Key: 282713369
• Report Number: 2134265-2021-16165
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0027793859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• 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