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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 Break (1069); Entrapment of Device (1212)
Patient Problem No Code Available (3191)
Event Date 07/22/2020
Event Type  Injury  
Event Description
It was reported that the balloon was caught in the stent and became separated.The 2.5mm in diameter target lesion was located in the mildly calcified first diagonal (d1) artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was delivered and expanded in the target lesion passing through the stent strut that was previously placed in the left anterior descending artery (lad).The angle of lad and d1 was about 30 degrees on the angiography.However, when the device was removed, it was caught by the stent strut and could not be removed; so surgical treatment was performed.Furthermore, the device was separated when it was removed by surgery, but no fragments remained in the patient's body.The procedure could not be completed by percutaneous coronary intervention, but the intended treatment was completed.No further complications were reported and the patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The distal section of the device including the cutting balloon, markerbands and tip were not returned for analysis.A visual and tactile examination identified a break in the shaft polymer extrusion 210mm distal from guidewire exit port.It was a clean break and looks to have been cut by the surgeon during the attempt to remove the device.A visual and tactile examination identified multiple hypotube kinks.The manifold was also noted to be detached from the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the balloon was caught in the stent and became separated.The 2.5mm in diameter target lesion was located in the mildly calcified first diagonal (d1) artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was delivered and expanded in the target lesion passing through the stent strut that was previously placed in the left anterior descending artery (lad).The angle of lad and d1 was about 30 degrees on the angiography.However, when the device was removed, it was caught by the stent strut and could not be removed; so surgical treatment was performed.Furthermore, the device was separated when it was removed by surgery, but no fragments remained in the patient's body.The procedure could not be completed by percutaneous coronary intervention, but the intended treatment was completed.No further complications were reported and the patient was stable post procedure.
 
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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 Key10443303
MDR Text Key204047059
Report Number2134265-2020-10934
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 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/03/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025152450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2020
Date Manufacturer Received09/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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