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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2024
Event Type  malfunction  
Event Description
It was reported that the catheter shaft broke.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the delivery shaft was fractured.The device was completely removed from the patient's body with a guide catheter and the procedure was completed with another of the same device.No patient complications were reported, and patient is stable post procedure.
 
Event Description
It was reported that the catheter shaft broke.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the delivery shaft was fractured.The device was completely removed from the patient's body with a guide catheter and the procedure was completed with another of the same device.No patient complications were reported, and patient is stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.No issues were noted with the hypotube shaft.The shaft polymer extrusion had no kinks or damages.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.Bumper distal tip was crushed.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.
 
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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 Key19084876
MDR Text Key340049850
Report Number2124215-2024-21987
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 05/14/2024
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 Number3851
Device Catalogue Number3851
Device Lot Number0031867816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2024
Initial Date FDA Received04/10/2024
Supplement Dates Manufacturer Received04/22/2024
Supplement Dates FDA Received05/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2023
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 Age68 YR
Patient SexFemale
Patient Weight62 KG
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