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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 Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  malfunction  
Event Description
It was reported that a metal object protruded from the balloon.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx2.00mm wolverine coronary cutting balloon was advanced but was unable to cross the lesion.The device was removed without resistance and it was noted there was a metal object protruding before the distal marker of the balloon catheter.The procedure was completed with a different device.No patient complications were reported and patient status was good.
 
Event Description
It was reported that a metal object protruded from the balloon.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx2.00mm wolverine coronary cutting balloon was advanced but was unable to cross the lesion.The device was removed without resistance and it was noted there was a metal object protruding before the distal marker of the balloon catheter.The procedure was completed with a different device.No patient complications were reported and patient status was good.
 
Manufacturer Narrative
Device evaluated by manufacturer: one of the blades approximately 2 mm proximal of the distal markerband was lifted from the balloon material.The balloon material was returned partially inflated with inflation medium within the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.
 
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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 Key9520640
MDR Text Key177135021
Report Number2134265-2019-16164
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 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/11/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024098999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2020
Date Manufacturer Received02/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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