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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was in a severely calcified vessel.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During procedure, it was noted that the balloon ruptured at 12 atm upon first inflation.The device was removed without any problem.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was in a severely calcified vessel.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During procedure, it was noted that the balloon ruptured at 12 atm upon first inflation.The device was removed without any problem.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body and the patient condition was good post procedure.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was in a severely calcified vessel.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During procedure, it was noted that the balloon ruptured at 12 atm upon first inflation.The device was removed without any problem.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body and the patient condition was good post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Based on the potential hazards/failure modes identified, the following attributes were examined: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified in the balloon which is indictaive of a leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located in the mid balloon.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The markerbands, blades and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple kinks on the hypotube of the device.No other issues were identified during the product analysis.
 
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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 Key9435090
MDR Text Key170298635
Report Number2134265-2019-15240
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,Followup
Report Date 02/10/2020
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 Model Number3851
Device Catalogue Number3851
Device Lot Number0024311726
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/08/2019
Supplement Dates Manufacturer Received11/26/2019
01/17/2020
Supplement Dates FDA Received12/11/2019
02/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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