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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 3852
Device Problems Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured.The target lesion was located in the right coronary artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was felt as the wolverine was delivered into the guide catheter.Eventually, the device was able to advance up to the lesion.However, at first inflation, it was noticed that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that the balloon ruptured.The target lesion was located in the right coronary artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was felt as the wolverine was delivered into the guide catheter.Eventually, the device was able to advance up to the lesion.However, at first inflation, it was noticed that the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: 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.An examination of the balloon identified a longitudinal tear in the balloon.The tear stretched from the distal balloon cone and extended 18 mm proximally along the balloon material.No issues were identified with the balloon material, blades or markerbands which could have contributed to the tear.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination found no issues with the hypotube of this device.The markerbands and tip and 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.
 
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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 Key11518747
MDR Text Key241065527
Report Number2134265-2021-03303
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 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/20/2022
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0025454833
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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