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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 Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the blade became short upon removal.The target lesion was located in the right coronary artery.A 10mmx3.50mm wolverine coronary cutting balloon was delivered into the lesion through a non-bsc guide support.During removal, however, resistance was felt at the collar part and the blade became short.The procedure was continued with a drug coated balloon and was completed successfully.There were no patient complications reported.
 
Manufacturer Narrative
E.Initial reporter city: (b)(6).Device evaluated by manufacturer.The device was returned for analysis.A 3.5 x 10mm wolverine catheter 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.The balloon was inflated to its rate of burst pressure of 12 atmospheres without issue.The inflation device was verified at 12 atmospheres, before and after use with a calibrated pressure gauge.No issues were identified with the balloon material.A microscopic examination identified that the distal section of one of the blades of the device measuring approximately 5mm had completely detached from its blade pad.The proximal section of the blade had lifted approximately 3mm at the distal end.2mm of the proximal blade section remained full bonded to the balloon material.The distal section of the blade was not returned for analysis.This type of damage is consistent with excessive force being applied to the device when encountering resistance.No issues or damage was noted to any of the other blades of the device.All other blades and blade pads remained fully bonded to the balloon material.A microscopic examination identified the tip of the device to be damaged.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no damage or kinks to the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the blade became short upon removal.The target lesion was located in the right coronary artery.A 10mmx3.50mm wolverine coronary cutting balloon was delivered into the lesion through a non-bsc guide support.During removal, however, resistance was felt at the collar part and the blade became short.The procedure was continued with a drug coated balloon and was completed successfully.There were no patient complications reported.
 
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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 Key10246789
MDR Text Key197996274
Report Number2134265-2020-08784
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 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/24/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024657740
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Date Manufacturer Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE SUPPORT- GUIDEPLUS ST; GUIDE SUPPORT- GUIDEPLUS ST; GUIDE SUPPORT- GUIDEPLUS ST
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