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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 3852
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Event Description
It was reported that a catheter shaft fracture occurred.The 21mmx2.9mm 68% stenosed target lesion was located in the mildly tortuous and mildly calcified left circumflex artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the shape of shaft was not in harmony, withdrew the catheter, and was about to cut again.However, it was found that the device was fractured.The procedure was completed with another of the same device.No patient complications and the patient was stable post procedure.
 
Manufacturer Narrative
A4 - weight: 44.6 kgs.
 
Manufacturer Narrative
A4 - weight: 44.6 kgs.Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon identified no damages.A hypotube break was noted at 60cm distal to the distal end of the strain relief.Multiple kinks were also noted.Tip showed no signs of tip damage.The shaft polymer extrusion showed no kinks or damages.A hypotube break was noted at 60cm distal to the distal end of the strain relief.Multiple kinks were noted in various locations along the length of the hypotube 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.A microscopic examination of the proximal and distal markerbands identified no damage.
 
Event Description
It was reported that a catheter shaft fracture occurred.The 21mmx2.9mm 68% stenosed target lesion was located in the mildly tortuous and mildly calcified left circumflex artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the shape of shaft was not in harmony, withdrew the catheter, and was about to cut again.However, it was found that the device was fractured.The procedure was completed with another of the same device.No patient complications and the patient was stable post procedure.
 
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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 Key18280841
MDR Text Key329898066
Report Number2124215-2023-69435
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
Report Date 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0031334851
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2023
Initial Date FDA Received12/07/2023
Supplement Dates Manufacturer Received01/18/2024
Supplement Dates FDA Received02/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2023
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 Age81 YR
Patient SexFemale
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