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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 11/08/2019
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10atm.The device was simply removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was good post procedure.
 
Event Description
It was reported that a balloon rupture occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10atm.The device was simply removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was good post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.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, the balloon was inflated to its rate of burst pressure of 12 atmospheres without issue.A vacuum was then applied.The inflation device was verified at 12 atmospheres, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 12 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was severely kinked at approximately 10mm proximal of the guidewire port.This is consistent with excessive force being applied to the device.No 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 Key9360016
MDR Text Key173460705
Report Number2134265-2019-14320
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 12/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
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 Number0024256590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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