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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 3852
Device Problems Material Rupture (1546); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified from proximal to mid left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon second inflation at 12 atmospheres for 10 seconds and that the blade was bent.The balloon was completely removed and the procedure completed with another of the same device.No complications were reported and the patient was good post procedure.
 
Event Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified from proximal to mid left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon second inflation at 12 atmospheres for 10 seconds and that the blade was bent.The balloon was completely removed and the procedure completed with another of the same device.No complications were reported and the patient was good post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon and inflation lumen identified no issues.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at 5mm proximal from the distal marker band.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands or tip of the device that may have potentially contributed to the complaint incident.The blades of the device were visually and microscopically examined.Blade 1: mid and distal blade segments had areas of lift from pad visible at break points and blade segments were bent.Blade 2: middle blade segment was lifted from pad at distal end and all blade segments were found to be bent.Blade 3: proximal blade segment was bent, and distal blade segment lifted from pad at break point.The blade damages most likely occurred when the device met resistance of a challenging tortuous anatomy and challenging calcified stenosed lesion.A visual and tactile examination found multiple kinks on several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination found no issues with the extrusion shaft of the device which may have potentially contributed to the reported incident.No shaft kinks were noted.No other issues were identified during the product analysis.
 
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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 Key11012629
MDR Text Key221809375
Report Number2134265-2020-17748
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,distri
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2022
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0026186603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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