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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 Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problems Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2022
Event Type  malfunction  
Manufacturer Narrative
Age at time of event- 18 years or older.Initial reporter address 1: (b)(6).
 
Event Description
It was reported that the blade penetrated in the lesion.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, dilation was performed twice and was deflated.However, the device got caught and penetrated in the lesion upon retrieval.It was then eventually retrieved but the blade was damaged; partially lifted.The procedure was completed with a different device.No further patient complications reported.
 
Event Description
It was reported that the blade penetrated in the lesion.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, dilation was performed twice and was deflated.However, the device got caught and penetrated in the lesion upon retrieval.It was then eventually retrieved but the blade was damaged; partially lifted.The procedure was completed with a different device.No further patient complications reported.It was further reported that the physician met resistance when removing the device, but it was just still simply removed.There was no damage on the vessel.
 
Manufacturer Narrative
Updated lot number, initial reporter last name and device codes.Corrected patient codes.A2.Age at time of event- 18 years or older e1.Initial reporter address(b)(6).Device evaluated by manufacturer: the device was returned 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 and was partially inflated with contrast media.The following blade damage was noted on one blade: approximately 1.5mm of a blade segment was missing.The pad was intact with no damage noted.No damage was observed to the remaining blades and pads.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.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16207467
MDR Text Key307715515
Report Number2124215-2022-56627
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 02/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/07/2024
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0028644566
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2022
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 Outcome(s) Other;
Patient SexMale
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