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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 Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported that the blade separated.A 6mmx3.50mm wolverine coronary cutting balloon was selected for procedure.During procedure, the blades were not on its outer surface after the balloon was inflated.The device was removed from the patient body.The procedure successfully was completed with another device.There were no patient complications and the patient was stable post procedure.
 
Event Description
It was reported that the blade separated.A 6mmx3.50mm wolverine coronary cutting balloon was selected for procedure.During procedure, the blades were not on its outer surface after the balloon was inflated.The device was removed from the patient body.The procedure successfully was completed with another device.There were no patient complications and the patient was stable post procedure.It was further reported that the target lesion was located in the left main artery.The wolverine cutting balloon was inflated to 12 atmospheres; however, the blades were not ready for action and did not appear properly.The blades did not detach from the device and there was no device fragments left inside the patient.
 
Manufacturer Narrative
Device evaluated by manufacturer: a 6mmx3.50mm wolverine coronary cutting balloon device was received for analysis.A visual and microscopic examination 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.A visual and microscopic examination identified no damage to the blades or balloon material.All blades were fully bonded to the surface of the balloon.A visual and tactile examination found no kinks present along the hypotube.A visual, microscopic and tactile examination found multiple kinks along the shaft polymer extrusion.There were no issues with the tip of the device.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that the blade separated.A 6mmx3.50mm wolverine coronary cutting balloon was selected for procedure.During procedure, the blades were not on its outer surface after the balloon was inflated.The device was removed from the patient body.The procedure successfully was completed with another device.There were no patient complications and the patient was stable post procedure.It was further report that the target lesion was located in the left main artery.The wolverine cutting balloon was inflated to 12 atmospheres; however, the blades were not ready for action and did not appear properly.The blades did not detach from the device and there was no device fragments left inside the patient.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12723415
MDR Text Key279276928
Report Number2134265-2021-13583
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeHU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/18/2023
Device Model Number3850
Device Catalogue Number3850
Device Lot Number0026653072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2021
Initial Date FDA Received10/29/2021
Supplement Dates Manufacturer Received11/02/2021
12/01/2021
Supplement Dates FDA Received11/10/2021
12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age84 YR
Patient SexMale
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