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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal-mid left anterior descending artery.A 10mm x 2.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at 4atm for 2-3 seconds.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: 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 returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at the site of the proximal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine label specification.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination found no kinks or damage tom the hypotube or shaft of the 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.
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal-mid left anterior descending artery.A 10mm x 2.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon first inflation at 4atm for 2-3 seconds.The procedure was completed with a different device.No patient complications were reported.
 
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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 Key10915116
MDR Text Key218674541
Report Number2134265-2020-16572
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/16/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025727829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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