BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 10602887 · Received September 29, 2020

    Report

    Report Number
    1820334-2020-01779
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 3, 2020
    Report Date
    November 17, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K142819
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. DESCRIPTION OF EVENT: AS REPORTED, DURING TREATMENT FOR AN OCCLUSION OF THE RIGHT LEG, A COOK FLEXOR SHEATH SEPARATED. THE SEPARATION WAS NOTED AS A BALLOON WAS BEING PULLED BACK AFTER DILATION. THE ANATOMY WAS NOT TORTUOUS; HOWEVER, IT WAS "MAYBE A LITTLE" CALCIFIED. THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER SHEATH TO COMPLETE THE PROCEDURE. INVESTIGATION ¿ EVALUATION. A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWINGS, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS MADE OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ A CAPA AS OPENED IN RESPONSE TO AN INCREASE IN FLEXOR SHEATH SEPARATION COMPLAINTS FROM 2018 TO 2019. THE CAPA INVESTIGATION IS ONGOING. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THE INVESTIGATION CONCLUSION COULD NOT ESTABLISH A DEFINITIVE CAUSE, BUT A POTENTIAL CAUSE CAN BE ATTRIBUTED TO THE PATENTS ANATOMY AS THE PHYSICIAN REPORTED THAT THE PATIENT WAS CALCIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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 REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Description of Event or Problem · 0

    CONFIRMATION OF ACCURATE DEVICE INFORMATION WAS RECEIVED ON 30SEP2020.

    Additional Manufacturer Narrative · 1

    CONFLICTING DEVICE INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER. CLARIFICATION HAS BEEN REQUESTED. THE TWO POSSIBLE RPNS ARE LISTED BELOW. POSSIBLE DEVICE 1: DEVICE NAME: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH, RPN: KSAW-7.0-38-80-RB-SHTL-HC, LOT: 8688996X, PMA/510K #: K142819. POSSIBLE DEVICE 2: DEVICE NAME: FLEXOR BALKIN GUIDING SHEATH, RPN: KCFW-8.0-38-40-RB-BLKN, PMA/510K #: K142829. (B)(6). 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 TREATMENT FOR AN OCCLUSION OF THE RIGHT LEG, A COOK FLEXOR SHEATH SEPARATED. THE SEPARATION WAS NOTED AS A BALLOON WAS BEING PULLED BACK AFTER DILATION. THE ANATOMY WAS NOT TORTUOUS; HOWEVER, IT WAS "MAYBE A LITTLE" CALCIFIED. THE SHEATH WAS REMOVED AND REPLACED WITH ANOTHER SHEATH TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE COMPLAINT DEVICE HAS BEEN REQUESTED TO CLARIFY THE IDENTITY OF THE SEPARATED SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066679 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC 8688996X

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR PTAX4-14-170-2.5-12.| RPC-35-260.