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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 Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Event Description
It was reported that lifted blade occurred.A 10mmx3.25mm wolverine coronary cutting balloon was introduced and lesion dilation was completed.When the device was removed, there was a large resistance near the y-connector and the blade appeared lifted.The device was not replaced and the procedure was completed as it was.There was no patient injury.
 
Manufacturer Narrative
A visual and microscopic examination of the returned device identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface however the following blade damage was noted on one blade: approximately 3mm of a proximal section of blade was lifted.The pad was intact with no damage noted.No damage was observed to the remaining blades.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that lifted blade occurred.A 10mmx3.25mm wolverine coronary cutting balloon was introduced and lesion dilation was completed.When the device was removed, there was a large resistance near the y-connector and the blade appeared lifted.The device was not replaced and the procedure was completed as it was.There was no patient injury.It was further reported that the physician already felt resistance in the coronary artery before withdrawing to the hemostatic valve.No blade damage was noted during preparation.The device was returned and analysis completed on 17sep2021.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted on one blade: approximately 3mm of a proximal section of blade was lifted.The pad was intact with no damage noted.No damage was observed to the remaining blades.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that lifted blade occurred.A 10mmx3.25mm wolverine coronary cutting balloon was introduced and lesion dilation was completed.When the device was removed, there was a large resistance near the y-connector and the blade appeared lifted.The device was not replaced and the procedure was completed as it was.There was no patient injury.It was further reported that the physician already felt resistance in the coronary artery before withdrawing to the hemostatic valve.No blade damage was noted during preparation.
 
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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 Key12310899
MDR Text Key266193113
Report Number2134265-2021-10323
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,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/13/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026966138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Date Manufacturer Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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