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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 Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2019
Event Type  malfunction  
Event Description
It was reported that distal tip detachment occurred.The 75% stenosed target lesions were located in the moderately tortuous and moderately calcified mid to distal left anterior descending artery and distal left circumflex artery.A 10mmx2.50mm wolverine cutting balloon was tried to advance along a non-bsc wire but considerable difficulty was encountered.Upon removal of the device, it was noted that the distal tip of the device came off.The procedure was completed using a 10mmx2.25mm wolverine balloon.No complications reported and patient condition was good.
 
Manufacturer Narrative
Lot number corrected from 2375388 to 0023753883.
 
Event Description
It was reported that distal tip detachment occurred.The 75% stenosed target lesions were located in the moderately tortuous and moderately calcified mid to distal left anterior descending artery and distal left circumflex artery.A 10mmx2.50mm wolverine cutting balloon was tried to advance along a non-bsc wire but considerable difficulty was encountered.Upon removal of the device, it was noted that the distal tip of the device came off.The procedure was completed using a 10mmx2.25mm wolverine balloon.No complications reported and patient condition was good.
 
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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 Key9262380
MDR Text Key166193861
Report Number2134265-2019-13152
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 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/06/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0023753883
Was Device Available for Evaluation? No
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE CATHETER- HYPERION6F SPB3.5.; GUIDE CATHETER- HYPERION6F SPB3.5.; GUIDEWIRE- RUNTHROUGH.; GUIDEWIRE- RUNTHROUGH.; INFLATION DEVICE- EVEREST.; INFLATION DEVICE- EVEREST.; INTRODUCER SHEATH-RADIFOCUS 6F.; INTRODUCER SHEATH-RADIFOCUS 6F.
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