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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 39345-401510
Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2023
Event Type  malfunction  
Event Description
It was reported that blade was partially separated.The 95% stenosed target lesion was located in the mildly tortuous and moderately calcified left superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the catheter was applied to several parts of the blood vessel.When the balloon was removed after inflation, it was noted that the blade was partially separated from the balloon.The balloon was able to be removed as usual and the blades were completely removed outside the body.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The balloon of the device was visually examined, and no issues were noted.A visual examination of the returned device identified that 5mm blade were noted to have lifted on the proximal end of one of the blades.All other blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.No other issues were identified during the product analysis.
 
Event Description
It was reported that blade was partially separated.The 95% stenosed target lesion was located in the mildly tortuous and moderately calcified left superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the catheter was applied to several parts of the blood vessel.When the balloon was removed after inflation, it was noted that the blade was partially separated from the balloon.The balloon was able to be removed as usual and the blades were completely removed outside the body.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
WOLVERINE PERIPHERAL CUTTING BALLOON
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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16686761
MDR Text Key312760153
Report Number2124215-2023-14397
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 05/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39345-401510
Device Catalogue Number39345-401510
Device Lot Number0030865560
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE: JUPITER; GUIDEWIRE: JUPITER; INTRODUCER SHEATH: PARENT; INTRODUCER SHEATH: PARENT
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