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

Model Number 3851

Device Problem Material Rupture (1546)

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)

Event Date 06/16/2021

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon ruptured, blood vessel lost, blood pressure dropped, and the patient died.The target lesion was located in the distal right coronary artery.A 10mm x 2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 10atm for 15 seconds.There was timi 0 flow in the distal right coronary artery.Subsequently, the blood pressure dropped, and patient died due to ineffective rescue.

Event Description

It was reported that the balloon ruptured, blood vessel lost, blood pressure dropped, and the patient died.The target lesion was located in the distal right coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 10atm for 15 seconds.There was timi 0 flow in the distal right coronary artery.Subsequently, the blood pressure dropped, and patient died due to ineffective rescue.

Manufacturer Narrative

E1: initial reporter facility name- (b)(6) hospital.Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified a build-up of solidified contrast media present inside the balloon.No tears were visible inside balloon.The device was soaked in a waterbath to soften the solidified media to facilitate balloon inflation and, upon removal, was attached to an encore inflation unit.During an attempt to inflate the balloon, a pinhole leak was confirmed in the balloon material.The pinhole was located at 2 mm proximal to the distal marker band.A microscopic examination of the balloon material and blades identified no issues which could potentially have contributed to the pinhole leak.A visual and tactile examination found no issues with the hypotube shaft.An examination of the inner extrusion, inside the balloon, found that the inner/wire lumen was kinked.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

• 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
• MDR Report Key: 12173518
• MDR Text Key: 261703213
• Report Number: 2134265-2021-08166
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026677741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 70