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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 Break (1069); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) university.
 
Event Description
It was reported that the device was fractured.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx3.50mm wolverine cutting balloon was selected for use.During the procedure, the delivery shaft of the balloon was fractured 20cm from the hub, and it could not cross.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.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx3.50mm wolverine cutting balloon was selected for use.During the procedure, the delivery shaft of the balloon was fractured 20cm from the hub, and it could not cross.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.
 
Manufacturer Narrative
E1 - initial reporter facility name: the first affiliated hospital of zhengzhou university device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.Multiple kinks were noted along hypotube shaft.No kinks or damages were noted along polymer shaft.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.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.
 
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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 Key18685204
MDR Text Key335124972
Report Number2124215-2024-07889
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,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/18/2024
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 Expiration Date09/01/2024
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0030078630
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2024
Initial Date FDA Received02/12/2024
Supplement Dates Manufacturer Received04/18/2024
Supplement Dates FDA Received04/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2022
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 Age55 YR
Patient SexMale
Patient Weight77 KG
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