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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); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
It was reported that device detachment occurred.The target lesion was an area of in-stent restenosis.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, resistance was felt during removal and there was a possibility that deflation was unable to perform properly.As a result, the blade was deformed and the blade was noted to be missing after the procedure.The physician was unable to confirm the blade location and there was possibility that the blade remained inside the patient.The procedure was completed with a different device.There was no patient injury reported.
 
Event Description
It was reported that device detachment occurred.The target lesion was an area of in-stent restenosis.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, resistance was felt during removal and there was a possibility that deflation was unable to perform properly.As a result, the blade was deformed and the blade was noted to be missing after the procedure.The physician was unable to confirm the blade location and there was possibility that the blade remained inside the patient.The procedure was completed with a different device.There was no patient injury reported.
 
Manufacturer Narrative
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.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 detached and was not received for analysis.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.The device was attached to an encore inflation unit and the balloon inflated to its rated burst pressure.A vacuum was applied and the balloon deflated fully in 2 seconds.No other issues were identified during the product analysis.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16676776
MDR Text Key312642677
Report Number2124215-2023-15350
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 Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0030674325
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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