BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIGN URETHRAL SUPPORT SYSTEM

    MDR report key: 1233944 · Received November 14, 2008

    Report

    Report Number
    1018233-2008-00079
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 14, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K070073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. RECEIVED TWO HANDLES, TWO RETROPUBIC NEEDLES WITH GREEN PLASTIC COVERS ON THE NEEDLE TIPS (SUPPLIED BY HOSPITAL), ONE SLING ASSEMBLY INCLUDING TWO FULLY ASSEMBLED GREEN TUBE TO PTFE SHEATH ASSEMBLIES WITH SWAGE BANDS. ONE OF THE GREEN TUBES IS APPROXIMATELY 14.9 CM LONG; THE OTHER IS APPROXIMATELY 14.5 CM LONG WITH SIGNS OF BENDING AND STRETCHING NEAR THE END. BOTH TUBES HAVE BEEN CUT FROM THE WHITE CONNECTORS. ONE OF THE NEEDLES HAS THE WHITE CONNECTOR AND APPROXIMATELY 0.6 CM OF GREEN TUBING STILL ATTACHED TO THE CONNECTOR. A BROKEN WHITE HINGED CONNECTOR WAS RETURNED STILL ATTACHED TO APPROXIMATELY 0.8 CM OF GREEN TUBING. THE BROKEN CONNECTOR SHOWS EVIDENCE OF STRETCHING FROM EXCESSIVE TENSILE STRESS (ELONGATION) AT THE POINT OF BREAKAGE (AT THE D-WINDOW) AND A PORTION OF THE CONNECTOR (THE CUP SECTION) WAS NOT RETURNED. THE RETURNED CONNECTOR SAMPLE WAS BROKEN ON BOTH SIDES OF THE D WINDOW. ONE SIDE OF THE CONNECTOR APPEARED TO BE A BRITTLE FRACTURE (CLEAN AND GLASSY FRACTURE SURFACE), WHILE THE OTHER SIDE HAD SIGNIFICANT ELONGATION AND STRESS WHITENING, WHICH IS AN INDICATION OF DUCTILE BREAK. AS A RESULT, ONE SIDE OF THE CONNECTOR WAS ABOUT 3-4 MM LONGER THAN THE OTHER SIDE DUE TO STRETCHING. THE CONNECTOR AND GREEN TUBE ALSO HAD SIGNS OF BEING SUBJECTED TO UNUSUALLY HIGH STRESSES, AS EVIDENCED BY THE STRESS WHITENING AROUND THE GREEN TUBE JOINT AND THE SMALLER NECKED-DOWN GREEN TUBE DIAMETER WHERE IT WAS JOINED TO THE CONNECTOR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING THE PROCEDURE IN 2008, THE HINGED CONNECTOR BROKE. THE DOCTOR PASSED THE DEVICE ON THE RIGHT SIDE WITHOUT INCIDENT. ON THE PATIENT'S LEFT SIDE, THE END OF THE TAPE CAME OFF WHILE THE DOCTOR WAS PASSING THE NEEDLE. IT WAS ALSO INITIALLY REPORTED THAT THE DOCTOR CUT THE GREEN TUBING AND CONNECTED IT DIRECTLY TO THE TROCAR. THE GREEN TUBING CAME OFF 2 ADDITIONAL TIMES. THE DOCTOR STATED THAT HE LOST A PIECE OF PLASTIC IN THE PATIENT AND OPTED TO LEAVE IT IN THE PATIENT SINCE HE COULD NOT FIND THE PIECE. ACCORDING TO THE DOCTOR, THERE HAVE BEEN NO KNOWN SYMPTOMS THAT THE PATIENT HAS EXPERIENCED. THE DOCTOR DID NOT NOTE ANY RESISTANCE THAT MIGHT HAVE CAUSED THE CONNECTOR BREAKAGE WHEN ADVANCING THE TROCAR DURING THE PROCEDURE. NO ADDITIONAL PROCEDURES HAVE BEEN PERFORMED. IF PRESENT, THE LOCATION OF THE INDWELLING PIECE OF THE CONNECTOR (APPROX. 3MM) WAS DESCRIBED AS POST PELVIC ON THE LEFT SIDE. DURING AN INTERVIEW WITH THE DOCTOR ON THE FOLLOWING MONTH, THE DOCTOR INDICATED THAT HE IS NOT CERTAIN THAT A PIECE OF THE CONNECTOR WAS LEFT BEHIND IN THE PATIENT AS ORIGINALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN URETHRAL SUPPORT SYSTEM FTL C.R. BARD, INC. NA HUSF1798

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention