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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 Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the device was difficult to remove.Vascular access was obtained via transforaminal injection.The 90% stenosed target lesion area was located in a severely tortuous and severely calcified mid left anterior descending artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.Ablation was performed by rotapro but the flow was slow so the burr was down sized to 1.25mm.After dilatation, ivus was performed to check the lesion.Remaining part was noted so dilatation was continued by the wolverine.Upon removal, the device was difficult to remove.Inflation and deflation was repeated several times and the device was removed.The device was inspected and the blade was deformed.The procedure was completed with another of the same device.No complications reported and the patient is stable.
 
Event Description
It was reported that the device was difficult to remove.Vascular access was obtained via transforaminal injection.The 90% stenosed target lesion area was located in a severely tortuous and severely calcified mid left anterior descending artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.Ablation was performed by rotapro but the flow was slow so the burr was down sized to 1.25mm.After dilatation, ivus was performed to check the lesion.Remaining part was noted so dilatation was continued by the wolverine.Upon removal, the device was difficult to remove.Inflation and deflation was repeated several times and the device was removed.The device was inspected and the blade was deformed.The procedure was completed with another of the same device.No complications reported and the patient is stable.It was further reported that the hub was removed to insert a non-boston scientific guide catheter to allow removal of the stuck wolverine from the patient.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.No issues were noted with the balloon material.Blade damage noted as follows: a blade segment at the proximal end of the blade was found to be lifted from pad at both ends - 1 mm of blade lifted, bent and raised out of pad.Proximal end of pad also lifted from balloon material (approx.2 mm in length).The same blade segment also lifted from pad at break point.No further issues noted with blade; blade 2 - 1 blade segment lifted from pad at break point - no issues noted with blade pad; blade 3 - 1 blade segment lifted from pad at break point - no issues noted with blade pad.The device was returned with its hub removed.The hub was not returned with the device.Multiple kinks were noted along the length of the hypotube.A severe kink was noted at the site of the guidewire port.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
 
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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 Key10722034
MDR Text Key212697778
Report Number2134265-2020-13908
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/12/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025594017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Date Manufacturer Received11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
IMAGING CATHETER-HDOC; IMAGING CATHETER-HDOC
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