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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 3850
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2023
Event Type  malfunction  
Event Description
It was reported that the device was fractured.A 6mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, when the device was advanced, it was found that its mid part was in the state of separation.When taken out, the shaft part of the catheter was fractured, 3cm from the hub.Also, the balloon was not dilated.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.
 
Event Description
It was reported that the device was fractured.A 6mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, when the device was advanced, it was found that its mid part was in the state of separation.When taken out, the shaft part of the catheter was fractured, 3cm from the hub.Also, the balloon was not dilated.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.It was further reported that, when the device was taken out, it was fractured at 3cm from the shaft part of the catheter.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon identified no damages.Multiple hypotube kinks were noted along the shaft of the device and a break was identified, 54.9cm distal to the distal end of the strain relief.No kinks or damages were noted along the polymer shaft.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Multiple hypotube kinks were noted along the shaft of the device and a break was identified, 54.9cm distal to the distal end of the strain relief.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.
 
Event Description
It was reported that the device was fractured.A 6mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, when the device was advanced, it was found that its mid part was in the state of separation.When taken out, the shaft part of the catheter was fractured, 3cm from the hub.Also, the balloon was not dilated.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.It was further reported that, when the device was taken out, it was fractured at 3cm from the shaft part of the catheter.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18180733
MDR Text Key328620552
Report Number2124215-2023-64037
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 12/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3850
Device Catalogue Number3850
Device Lot Number0031615378
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age65 YR
Patient SexMale
Patient Weight70 KG
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