BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBER GUIDING CATHETER

    MDR report key: 5161513 · Received April 8, 2004

    Report

    Report Number
    6000128-2004-00002
    Event Type
    Injury
    Date Received
    April 8, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 16, 2004
    Manufacturer
    AVAIL
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETAINED BY THE FACILITY, THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE PERFORMED. THE SHOP FLOOR PAPERWORK FOR BATCH (B)(4) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SFP REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE FOR THE DIFFICULTIES EXPERIENCED IN THE COMPLAINT COULD NOT BE DETERMINED. BOSTON SCIENTIFIC MANUFACTURING PROCESSES INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS OR EXCEEDS MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY TREATMENT PROCEDURE, THE GUIDE CATHETER FRACTURED UPON INSERTION OF THE DEVICE INTO THE PATIENT. THE PHYSICIAN ATTEMPTED TO SNARE THE DEVICE, BUT WAS UNABLE TO DO SO. THE PATIENT UNDERWENT EMERGENT BILATERAL GROIN EXPLORATORY SURGERY FOR REMOVAL OF A 12FR SHEATH, THE CATHETER SEGMENT WHICH WAS APPROXIMATELY 12 INCHES IN LENGTH AND REPAIR OF THE FEMORAL ARTERY. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN OUT-PATIENT BASIS, BUT THE PATIENT REQUIRED HOSPITALIZATION FOLLOWING THE SURGERY. THE PATIENT WAS DISCHARGED AFTER 2 DAYS AND IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBER GUIDING CATHETER CORONARY GUIDING CATHETER LOX AVAIL 8F CY FL3.5 223626

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R