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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 3850
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2021
Event Type  malfunction  
Event Description
It was reported that the delivery shaft was fractured.The 95% stenosed target lesion was located in the mildly tortuous and non calcified distal right coronary artery.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was bent and fractured.The device was removed directly and the procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
 
Event Description
It was reported that the delivery shaft was fractured.The 95% stenosed target lesion was located in the mildly tortuous and non calcified distal right coronary artery.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was bent and fractured.The device was removed directly and the procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon wings were found to be in a deflated state.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.A hypotube break was identified at 33cm distal from the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination was completed, and no issues were noted.
 
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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 Key12019279
MDR Text Key256807831
Report Number2134265-2021-07482
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 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/25/2023
Device Model Number3850
Device Catalogue Number3850
Device Lot Number0026693123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
Patient Weight75
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