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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 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon ruptured.During a procedure, the 10mm x 2.50mm wolverine coronary cutting balloon ruptured at 6 atmospheres.The device was removed and the procedure completed with another of the same device.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon ruptured.During a procedure, the 10mm x 2.50mm wolverine coronary cutting balloon ruptured at 6 atmospheres.The device was removed and the procedure completed with another of the same device.It was further reported that the balloon was simply pulled out from the patient's body and the patient was good post procedure.
 
Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).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.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 5mm distal to the distal end of the proximal markerband.An examination of the balloon material and markerband identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no kinks or damage to the shaft or hypotube of the returned device.The markerbands and blades 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 microscopic examination identified damage to the tip of the device.This type of damage is consistent with excessive force being applied to the device when attempting to cross the target lesion.No issues were identified during the product analysis.
 
Event Description
It was reported that balloon ruptured.During a procedure, the 10mm x 2.50mm wolverine coronary cutting balloon ruptured at 6 atmospheres.The device was removed and the procedure completed with another of the same device.It was further reported that the balloon was simply pulled out from the patient's body and the patient was good 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 Key9527400
MDR Text Key177145267
Report Number2134265-2019-16233
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 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/26/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024022404
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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