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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 Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Event Description
It was reported that the device would not inflate.During the procedure, it was not possible to inflate the balloon.The device was replaced to complete the procedure.There were no patient injuries reported.However, the return device analysis revealed a pinhole leak in the device.
 
Manufacturer Narrative
Device evaluated by manufacturer: a wolverine cb mr, ous 10mmx3.00mm was returned for analysis.A visual and microscopic examination of the balloon identified no tears or holes in the balloon material.The device was attached to an encore inflation and during an initial attempt to inflate the balloon, a pinhole leak was identified in the balloon material.The pinhole was located just distal to the proximal marker band.No issues were identified with the balloon which could have contributed to the pinhole leak.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination of the hypotube/shaft found no kinks or damages.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands which could potentially have contributed to the pinhole leak.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key17083290
MDR Text Key317092091
Report Number2124215-2023-29209
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/07/2023
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 Number0030599432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/26/2023
Initial Date FDA Received06/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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