BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH

    MDR report key: 4811707 · Received May 29, 2015

    Report

    Report Number
    1820334-2015-00321
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 5, 2015
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED TO THE CORRECT SPECIFICATIONS. MANUFACTURING CONTROLS ARE IN PLACE TO MINIMIZE THE OCCURRENCE OF MATERIAL SEPARATION AND A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NONCONFORMANCES. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION; THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AND COMPLAINT HISTORY FOR THIS FAILURE MODE AND PRODUCT FAMILY. WITHOUT BENEFIT OF INSPECTING THE COMPLAINT DEVICE, IT IS DIFFICULT TO DETERMINE WITH CERTAINTY WHY THIS FAILURE MODE OCCURRED AND NO CONCLUSION CAN BE DRAWN ABOUT THE CAUSE FOR THIS EVENT. BASED ON THE RISK ASSESSMENT PERFORMED, NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL WILL BE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DURING A PERIPHERAL INTERVENTION PROCEDURE ON A (B)(6) YEAR OLD MALE PT WITH PAD AND DIABETES. THE TIP BROKE OFF INSIDE THE PT. THE STAINLESS STEEL COIL WAS STILL INTACT ALLOWING THE FACILITY TO CAREFULLY REMOVED THE BROKEN OFF FLEXOR MATERIAL. THE PROCEDURE WAS COMPLETED AS THIS WAS TOWARDS THE END OF THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING A PERIPHERAL INTERVENTION PROCEDURE ON A (B)(6) MALE PATIENT WITH PAD AND DIABETES, THE TIP BROKE OFF INSIDE THE PATIENT. THE STAINLESS STEEL COIL WAS STILL INTACT ALLOWING THE FACILITY TO VERY CAREFULLY REMOVE THE BROKEN OFF FLEXOR MATERIAL. THE PROCEDURE WAS COMPLETED AS THIS WAS TOWARDS THE END OF THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349612 FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC N/A 5562738

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR