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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 Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2020
Event Type  malfunction  
Event Description
It was reported that the device separated.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.Prior procedure, a damage in the mid shaft part was noted; appeared to be separated.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 tightly wrapped and had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.The inner lumen damage was noted on the shaft polymer extrusion of this device.The inner lumen was found to be bunched at 8cm distal to the guidewire port.Multiple hypotube kinks were also noted on the device.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that the device separated.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.Prior procedure, a damage in the mid shaft part was noted; appeared to be separated.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 Key10852019
MDR Text Key216934710
Report Number2134265-2020-15767
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 12/16/2020
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 Date07/08/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025684925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Initial Date Manufacturer Received 10/26/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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