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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 Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2024
Event Type  malfunction  
Event Description
It was reported that the device was stuck with the guidewire.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified popliteal artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the wolverine balloon got stuck with the non boston scientific guidewire.The devices were removed as unit and the procedure was completed.No patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis with the hub/manifold removed.The hub was not returned for analysis.As per the ifu the recommended guidewire size for this device is 0.014".The guidewire used by the customer was not returned for analysis.A visual examination was performed on the returned device, and it was noted that approximately 5mm of the proximal end of one of the blades was lifted distally from the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual and tactile examination found the hypotube of the device to be kinked at approximately 380mm proximal of the bi-component bond.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual examination identified that the balloon was not folded, which indicates that the balloon was subjected to positive pressure.No issues were identified with the balloon material.No issue was observed with the tip or markerbands of the device.
 
Event Description
It was reported that the device was stuck with the guidewire.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified popliteal artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the wolverine balloon got stuck with the non boston scientific guidewire.The devices were removed as unit and the procedure was completed.No patient complications reported.It was further reported that the hub part got in the way when removing the system, so it was cut.
 
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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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18681628
MDR Text Key335094287
Report Number2124215-2024-07369
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,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2024
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 Number0032265236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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