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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
It was reported that a blade detachment occurred.The target lesion was located in the highly calcified distal right coronary artery (rca).A 10 mm x 2.75 mm wolverine coronary cutting balloon was selected for use.After dilation of the lesion, there was resistance during removal.When the device was checked after it was pulled outside the patient, it was noted that the blade detached.Consequently, the guide catheter and guide extension catheter were removed, flushed and the blade came out.The blade was removed outside patient's body, and the procedure was completed with this device.As per physician's opinion, the cause of the blade detachment was due to the highly calcified lesion, there were a possibility that the high-pressure inflation of the balloon could not withstand the pressure and the blade might have kinked and separated.There were no patient complications reported.
 
Event Description
It was reported that a blade detachment occurred.The target lesion was located in the highly calcified distal right coronary artery (rca).A 10 mm x 2.75 mm wolverine coronary cutting balloon was selected for use.After dilation of the lesion, there was resistance during removal.When the device was checked after it was pulled outside the patient, it was noted that the blade detached.Consequently, the guide catheter and guide extension catheter were removed, flushed and the blade came out.The blade was removed outside patient's body, and the procedure was completed with this device.As per physician's opinion, the cause of the blade detachment was due to the highly calcified lesion, there were a possibility that the high-pressure inflation of the balloon could not withstand the pressure and the blade might have kinked and separated.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual, tactile and microscopic examination was performed on the device.A visual and tactile examination of hypotube shaft and shaft polymer extrusion identified no damages.A detailed microscopic examination of the balloon material identified no tears or holes in the balloon material.A microscopic examination of the blade identified that some damage existed to the blades.There was no damage on blade one.Blade and pad fully bonded onto the balloon.Blade two had detached from the proximal section approximately 2mm.The detached blade was not received for analysis.The pad at the detached section of blade was fully intact and bonded to the balloon.The entire blade three segment had detached from the balloon.Only approximately 5mm of the blade segment was received detached.The remaining 5mm of blade was not returned with the device.Further analysis of the balloon noted that the blade pad was fully bonded to the balloon.There were no issues identified during microscopic examination of the extrusion shaft.A microscopic examination of the tip section found no damage.Inspection of the remainder of the device, revealed no damage or irregularities.
 
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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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18743402
MDR Text Key336675456
Report Number2124215-2024-09758
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 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
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 Number0033093747
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2023
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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