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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3855
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2019
Event Type  malfunction  
Event Description
It was reported that blades came off.The target lesion was in the left anterior descending artery.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the cutting balloon blades came off after the inflation.No complications reported and the patient is fine.
 
Event Description
It was reported that blades came off.The target lesion was in the left anterior descending artery.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the cutting balloon blades came off after the inflation.No complications reported and the patient is fine.It was further reported the 60% stenosed target lesion was in a mildly tortuous artery.The device was completely removed as the blade was not completely detached from the balloon.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.All four blades were present and fully attached to the balloon as per wolverine specification.No issues were noted with the blades.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole 3mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.A visual examination identified no issues with the tip.A visual and tactile examination identified no issues.A visual and tactile examination found the hypotube of the device to be kinked at more than one location.No other issues were identified during the product analysis.
 
Event Description
It was reported that blades came off.The target lesion was in the left anterior descending artery.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the cutting balloon blades came off after the inflation.No complications reported and the patient is fine.It was further reported the 60% stenosed target lesion was in a mildly tortuous artery.The device was completely removed as the blade was not completely detached from the balloon.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON
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 Key9437455
MDR Text Key175899928
Report Number2134265-2019-15233
Device Sequence Number1
Product Code NWX
UDI-Device Identifier08714729888390
UDI-Public08714729888390
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/12/2021
Device Model Number3855
Device Catalogue Number3855
Device Lot Number0023946569
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2019
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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