BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 9235163 · Received October 24, 2019

    Report

    Report Number
    1820334-2019-02686
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    October 11, 2019
    Report Date
    March 24, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002299825
    PMA / PMN Number
    K142829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. PMA/510(K) = K142829 EVENT SUMMARY AS INITIALLY REPORTED, DURING A "LEGS DOTTER" PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED IN THE PATIENT. THE USER WAS "OPENING OCCLUSIONS" IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA LEFT-SIDED ACCESS OVER THE BIFURCATION. AFTER THE PROCEDURE, DURING RETRACTION OF THE DEVICE FROM THE RIGHT SIDE, THE SHEATH SEPARATED INTO TWO PIECES. THE SEPARATED PORTION WAS IN THE RIGHT EXTERNAL ILIAC ARTERY OVER AN UNKNOWN WIRE GUIDE. PER THE REPORTER, THE DEVICE WAS RETRIEVED VIA RETROGRADE ACCESS OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, USING A SNARE AND "BODY FLOSS". A SMALL LESION OF THE EXTERNAL ILIAC WAS REPORTED, "DUE TO THE BROKEN PART". REPORTEDLY, "THEY HAD TO DO A DOTTER AND DO A PTA TO CLOSE THE LESION". INVESTIGATION - EVALUATION REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE COMPLETE SEPARATION OF THE DISTAL 14.5CM OF THE DEVICE. BIOMATTER WAS PRESENT. THE DILATOR COULD NOT BE REMOVED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO RELATED NONCONFORMANCES WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. A REVIEW OF COMPLAINT HISTORY SHOWED NO COMPLAINTS REPORTED ON THE PRODUCT LOT OR SUBASSEMBLY LOTS. REVIEWS OF THE QUALITY CONTROL PROCEDURES AND MANUFACTURING INSTRUCTIONS WERE ALSO CONDUCTED, AND NO GAPS WERE DISCOVERED. THERE IS THUS NO EVIDENCE OF NONCONFORMING DEVICES PRESENT IN THE LOT, IN HOUSE OR IN THE FIELD. THE DEVICE IS PACKAGED WITH INSTRUCTIONS FOR USE, WHICH THAT IF RESISTANCE IS ENCOUNTERED DURING SHEATH ADVANCEMENT, ¿ASSESS CAUSE OF RESISTANCE AND CONSIDER DILATION OF ANY RESTRICTION IDENTIFIED OR CONSIDER ALTERNATE TREATMENT STRATEGY. IF FLEXOR SHEATH IS ADVANCED THROUGH RESISTANCE, FORCE TO REMOVE THE SHEATH WILL BE HIGHER, INCREASING THE RISK OF SHEATH MATERIAL OR HUB SEPARATION UPON WITHDRAWAL." A PREVIOUSLY CLOSED CAPA DETERMINED THAT FORCED ADVANCEMENT THROUGH RESTRICTIVE ANATOMIES AND FAILURE TO REINSERT THE DILATOR PRIOR TO DEVICE REMOVAL ARE BOTH PRIMARY CONTRIBUTING FACTORS TO SHEATH SEPARATIONS. BASED ON THE INFORMATION PROVIDED AND INSPECTION OF THE RETURNED DEVICE, INVESTIGATION HAS CONCLUDED THAT A CAUSE FOR THE DEVICE FAILURE COULD NOT BE ESTABLISHED. POSSIBLE CAUSES FOR THIS DEVICE FAILURE INCLUDE PATIENT ANATOMY, THE NATURE OF THE PROCEDURE, AND USER HANDLING OF THE DEVICE. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN PREVIOUSLY INITIATED TO FURTHER INVESTIGATE THIS FAILURE MODE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) NUMBER = PRE-AMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS INITIALLY REPORTED, DURING A "LEGS DOTTER" PROCEDURE, A FLEXOR ANSEL GUIDING SHEATH SEPARATED IN THE PATIENT. THE USER WAS "OPENING OCCLUSIONS" IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA LEFT-SIDED ACCESS OVER THE BIFURCATION. AFTER THE PROCEDURE, DURING RETRACTION OF THE DEVICE FROM THE RIGHT SIDE, THE SHEATH SEPARATED INTO TWO PIECES. THE SEPARATED PORTION WAS IN THE RIGHT ILIAC ARTERY OVER AN UNKNOWN WIRE GUIDE. PER THE REPORTER, THE DEVICE WAS RETRIEVED VIA RETROGRADE ACCESS OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, USING A SNARE AND "BODY FLOSS". A SMALL LESION OF THE EXTERNAL ILIAC WAS REPORTED, "DUE TO THE BROKEN PART". REPORTEDLY, "THEY HAD TO DO A DOTTER AND DO A PTA TO CLOSE THE LESION". AFTER THE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) WAS PERFORMED, THE "RESULT BETTER". ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. THE PHYSICIAN IS REPORTEDLY ON VACATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029824 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G29982 9983065 00827002299825

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention