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

Model Number 3854

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Event Description

It was reported that a device was not able to be visualized under fluoroscopy.A percutaneous coronary intervention was being performed.The 10mm x 3.0mm wolverine coronary cutting balloon was placed inside the patient's body.Once inflated, the physician was unable to see the balloon under fluoroscopy.The device was removed from the patient to be tested.The balloon inflated appropriately and the indeflator was checked for proper contrast.Once outside the patient, the balloon was again put under fluoroscopy and it was still not able to be visualized.The physician used another wolverine to complete the procedure.

Event Description

It was reported that a device was not able to be visualized under fluoroscopy.A percutaneous coronary intervention was being performed.The 10mm x 3.0mm wolverine coronary cutting balloon was placed inside the patient's body.Once inflated, the physician was unable to see the balloon under fluoroscopy.The device was removed from the patient to be tested.The balloon inflated appropriately and the indeflator was checked for proper contrast.Once outside the patient, the balloon was again put under fluoroscopy and it was still not able to be visualized.The physician used another wolverine to complete the procedure.

Manufacturer Narrative

Device returned to manufacturer: the wolverine coronary cutting balloon was returned and analysis was completed.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was attached to a boston scientific encore inflation unit and positive pressure was applied and the balloon was inflated to its rated burst pressure using a solution of omnipaque and sodium chloride (nacl), mixed in 50:50 ratio.The inflation device was verified at 12atm (atmospheres), before and after use.The inflated device was placed under a c-arm fluoroscope and x-ray images were taken of the balloon section of the device.Fluoroscopy images clearly showed the balloon profile and markerbands of the returned device.No issues were noted with the tip section of the device.

• 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
• MDR Report Key: 8619860
• MDR Text Key: 145385232
• Report Number: 2134265-2019-05057
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0023489138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 07/02/2019
• Patient Sequence Number: 1