BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH

    MDR report key: 9781404 · Received March 3, 2020

    Report

    Report Number
    1820334-2020-00535
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 26, 2020
    Report Date
    April 27, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002490437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTION B5: THIS EVENT OCCURRED DURING THE SAME PROCEDURE AS THE EVENT THAT HAS BEEN REPORTED UNDER PATIENT IDENTIFIER (B)(4). THIS INFORMATION WAS AVAILABLE AND INADVERTENTLY OMITTED FROM THE INITIAL MDR. SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED AT THE HUB DURING REPOSITIONING OF THE DEVICE. AN UNKNOWN GUIDE WIRE WAS IN THE LUMEN OF THE DEVICE WHEN THE HUB SEPARATED. NORMAL RESISTANCE WAS REPORTED AS THE SHEATH WAS MOVED OVER THE CALCIFIED AORTIC BIFURCATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE COMPLAINT DEVICE CONFIRMED THAT ONE USED FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS RETURNED FOR INVESTIGATION. BIOMATTER WAS PRESENT ON THE DEVICE AND THE HUB WAS DETACHED. THE INNER DIAMETER OF THE CAP WAS MEASURED AND WAS WITHIN SPECIFICATION. NO OTHER ISSUES WERE IDENTIFIED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, VALIDATIONS, AND MANUFACTURING DOCUMENTS PROVIDE OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. THE PRODUCT IFU STATES: "IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OF FLEXOR SHEATH, 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." "REINSERTION OF THE DILATOR PRIOR TO REMOVAL OF FLEXOR SHEATH INCREASES THE STRENGTH OF THE SHEATH AND LESSENS THE RISK OF DEVICE SEPARATION. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OR FLEXOR SHEATH, CONSIDER CAREFULLY REINSERTING THE DILATOR PRIOR TO CONTINUING REMOVAL." THE IFU ALSO STATES: "AVOID APPLYING TRACTION TO HUB DURING REMOVAL." A REVIEW OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THIS EVENT CANNOT BE TRACED TO THE DEVICE, BUT RATHER TO THE PATIENT¿S ANATOMY AND THE PROCEDURE, AS THE BIFURCATION WAS REPORTEDLY CALCIFIED. A PREVIOUSLY COMPLETED CAPA CONCLUDED THAT THE ABILITY TO ADVANCE FLEXOR DEVICES INTO RESTRICTIVE ANATOMIES IS A CONTRIBUTING FACTOR FOR THIS FAILURE MODE. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ACTION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: POSTAL (B)(6). OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K142829. 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 REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED AT THE HUB DURING REPOSITIONING OF THE DEVICE. AN UNKNOWN GUIDE WIRE WAS IN THE LUMEN OF THE DEVICE WHEN THE HUB SEPARATED. NORMAL RESISTANCE WAS REPORTED AS THE SHEATH WAS MOVED OVER THE CALCIFIED AORTIC BIFURCATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244700 FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G49043 10171586 00827002490437

    Patients

    Seq Age Sex Outcome Treatment
    1