BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 9334672 · Received November 18, 2019

    Report

    Report Number
    1820334-2019-02905
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 26, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002299856
    PMA / PMN Number
    K142829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION-G5: PMA/510(K)= K142829. DESCRIPTION OF EVENT: AS INITIALLY REPORTED, WHILE PREPPING A DEVICE FOR AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH WAS REPORTEDLY FLARED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. INVESTIGATION - EVALUATION REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE FLEXOR ANSEL GUIDING SHEATH WAS RETURNED TO COOK FOR INVESTIGATION. UPON INSPECTING THE DEVICE, NO VISIBLE DAMAGE TO THE SHEATH WAS NOTED, NOR WAS BIO MATTER PRESENT ON THE DEVICE. HOWEVER, SPLIT DAMAGE WAS NOTED TO THE TIP OF THE DILATOR. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE COMPLAINT LOT WAS THUS CONCLUDED TO BE MANUFACTURED TO CURRENT SPECIFICATIONS. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES, ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ GIVEN THE PROVIDED INFORMATION, COOK HAS CONCLUDED THAT A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, POSSIBLE CAUSES FOR THE REPORTED EVENT ARE THE SHIPPING AND HANDLING OF THE DEVICE. 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. 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

    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.

    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

    OCCUPATION = LEAD TECH. PMA/510(K) NUMBER = PRE-AMENDMENT. DEVICE EVALUATED BY MFG = DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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, WHILE PREPPING A DEVICE FOR AN UNKNOWN PROCEDURE, THE TIP OF A FLEXOR ANSEL GUIDING SHEATH WAS REPORTEDLY FLARED. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 15NOV2019, THE TIP OF THE SHEATH WAS NOT DAMAGED; HOWEVER, THE TIP OF THE DILATOR WAS NOTED TO BE SPLIT. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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
    1133229 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G29985 9840016 00827002299856

    Patients

    Seq Age Sex Outcome Treatment
    1