BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 3853475 · Received May 28, 2014

    Report

    Report Number
    1820334-2014-00216
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 22, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTRODUCER WAS RETURNED IN A USED AND DAMAGED CONDITION. THE SHEATH WAS TORN ALTHOUGH INTACT AT APPROXIMATELY THE MIDPOINT WITH EVIDENCE OF THINNING AND ELONGATION. AT THE TORN SITE, THE COIL HAD UNRAVELED AND SEPARATED WITH A PORTION MISSING RESULTING IN MINOR HARM TO THE PATIENT. QUALITY CONTROL INSURES THE CORRECT INSIDE DIAMETER AND OUTSIDE DIAMETER OF TUBING AND INSURES THE MATERIAL IS FREE FROM SURFACE DEFECTS, BUMPS, BULGES AND PROTRUDING OILS. IN ADDITION, THE INSTRUCTIONS FOR USE CAUTIONS THE END USER, "ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. SEPARATION OF THE SHEATH MAY RESULT WHEN THE FIT IS TIGHT". AS WELL AS THE WARNING, "BEFORE WITHDRAWING THE SHEATH THROUGH TORTUOUS ANATOMY, INSERT THE INTRODUCER DILATOR TO AVOID POSSIBLE BREAKAGE." DESIGN VERIFICATION TESTING HAS CONFIRMED SHEATH STRENGTH PER ISO 11070. ALTHOUGH NOT REPORTED, PRIOR COMPLAINTS OF INTRODUCER SEPARATION SUPPORT SEVERE CONTACT WITH THE STENT DEVICE IN THE LUMEN OR WITH A CALCIFIED LESION EXTERNALLY AS PROBABLE CAUSES; HOWEVER, NEITHER CAN BE DETERMINED WITH ANY DEGREE OF CERTAINTY WITHOUT ADDITIONAL INFORMATION FROM THE CUSTOMER. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. QUALITY ENGINEERING RISK ASSESSMENT CONCLUDED THAT WITH THE ADDITION FO THIS EVENT THERE IS INSUFFICIENT RISK TO REQUIRE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, INSTRUCTIONS FOR USE (IFU), TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE FLEXOR ANSEL GUIDING SHEATH INTRODUCER WAS RETURNED IN A USED AND DAMAGED CONDITION. THE SHEATH WAS TORN, THOUGH INTACT, AT APPROXIMATELY THE MIDPOINT WITH EVIDENCE OF THINNING AND ELONGATION. AT THE TORN SITE, THE COIL HAD UNRAVELED AND SEPARATED WITH A PORTION MISSING. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES HAVE BEEN CONDUCTED TO ADDRESS THIS FAILURE MODE. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE FLEXOR ANSEL GUIDING SHEATH TORE AND PART OF THE INTRODUCER RIPPED AND REMAINED IN THE PATIENT RISKING A THROMBOSIS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312843 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC NA 4842130

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| O