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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 Break (1069); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  Injury  
Event Description
It was reported that the catheter separated.Vascular access was obtained utilizing the contralateral approach.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal superficial femoral artery.A 4.00mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, due to the tight angle and bifurcation, the device was pushed and pulled several times when crossing through the stenosis.The balloon failed to inflate on the third inflation.When attempting to pull the shaft of the device back into the guide catheter sheath, separation around the lumen occurred around the tip of the guide catheter sheath and was collected with a snare.The procedure was completed with a different device and there was no patient injury reported.
 
Event Description
It was reported that the catheter separated.Vascular access was obtained utilizing the contralateral approach.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal superficial femoral artery.A 4.00mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, due to the tight angle and bifurcation, the device was pushed and pulled several times when crossing through the stenosis.The balloon failed to inflate on the third inflation.When attempting to pull the shaft of the device back into the guide catheter sheath, separation around the lumen occurred around the tip of the guide catheter sheath and was collected with a snare.The procedure was completed with a different device and there was no patient injury reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the shaft was completely separated at the monorail port.The distal section of the device including the balloon was not returned for analysis.This type of damage is consistent with the applying excessive tensile force to remove the device from the patient, causing device separation.No other issues were identified with the shaft of the device.The distal section of the device including the balloon, blades, markerbands and tip was not returned for analysis.
 
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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 Key18764465
MDR Text Key336052096
Report Number2124215-2024-09907
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 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39345-401510
Device Catalogue Number39345-401510
Device Lot Number0032890938
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE- COMMAND 300; GUIDEWIRE- COMMAND 300; INTRODUCER SHEATH- DESTINATION 6F; INTRODUCER SHEATH- DESTINATION 6F; MICRO CATHETER- CARAVEL; MICRO CATHETER- CARAVEL
Patient Outcome(s) Required Intervention;
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