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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 Material Rupture (1546); Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, a non-boston scientific guide extension catheter was inserted first.This device was delivered to the lesion using the guide extension catheter.It was noted that resistance was felt at the collar section of the guide extension catheter.An inflation was attempted but the balloon would not inflate.It was noted that the balloon ruptured upon first inflation.The guide extension catheter caused damage to the balloon, and that damage led to balloon rupture.The procedure was completed with another of the same device.No complications were reported and there was no patient injury.
 
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon and inflation lumen identified no issues.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at the site of the proximal end of the proximal marker band.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of 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 found no issues with the shaft of the device which may have potentially contributed to the reported incident.No shaft kinks were noted at the distal end of the tip.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, a non-boston scientific guide extension catheter was inserted first.This device was delivered to the lesion using the guide extension catheter.It was noted that resistance was felt at the collar section of the guide extension catheter.An inflation was attempted but the balloon would not inflate.It was noted that the balloon ruptured upon first inflation.The guide extension catheter caused damage to the balloon, and that damage led to balloon rupture.The procedure was completed with another of the same device.No complications were reported and there was no patient injury.
 
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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 Key10977939
MDR Text Key220637763
Report Number2134265-2020-17100
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/22/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0023997317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Date Manufacturer Received01/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE EXTENSION CATHETER - GUIDEPLUS2; GUIDE EXTENSION CATHETER - GUIDEPLUS2
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