BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RTPS GUIDING SHEATH

    MDR report key: 8726539 · Received June 24, 2019

    Report

    Report Number
    1820334-2019-01502
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 20, 2019
    Report Date
    March 20, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002130814
    PMA / PMN Number
    K142829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. D11: COOK GUNTHER TULIP IVC FILTER 25MM GOOSE-NECK SNARE, UNKNOWN MANUFACTURER. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE USED KCF-10.0-35-RB-RTPS-100 SHEATH WAS RETURNED WITHOUT THE INNER DILATOR. THE VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED MINIMAL BIOMATTER. THE DISTAL TIP WAS FOLDED INWARD. ON UNFOLDING THE TIP, THE OVERALL SHEATH LENGTH MEASURED 38.5CM. THE DISTAL END OF THE SHEATH LUMEN WAS OCCLUDED, AND THE DISTAL TUBING DID NOT HAVE COILING. THE MARKER BEND WAS NOT VISIBLE. THE SHEATH WAS CUT TO FIND THE SOURCE OF OCCLUSION. TWEEZERS WERE USED TO PULL OUT EXTENSIVE TNRT INNER LINER, THE RADIOPAQUE MARKER BAND, AND COILING. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE DEVICE IS PACKAGED WITH INSTRUCTIONS FOR USE (IFU), WHICH STATE ¿FLEXOR INTRODUCERS AND GUIDING SHEATHS ARE INTENDED TO INTRODUCE THERAPEUTIC OR DIAGNOSTIC DEVICES INTO THE VASCULATURE, EXCLUDING CORONARY AND NEURO VASCULATURE." BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THE DEVICE FAILURE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR, LIKELY DUE TO THE GUNTHER TULIP FILTER LEGS CATCHING ON THE DISTAL TIP OF THE SHEATH. 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. 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 NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    OCCUPATION: LEAD TECH. PMA/510(K) #: PREAMENDMENT. 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

    IT WAS REPORTED A FLEXOR RTPS GUIDING SHEATH WAS USED IN AN UNKNOWN PATIENT FOR AN INFERIOR VENA CAVA FILTER REMOVAL. AS REPORTED, DURING THE ATTEMPTED REMOVAL OF THE SHEATH THE "MARKER TIP CAME OFF OF THE SHEATH AND WENT INSIDE THE SHEATH...EVERYTHING WAS REMOVED SUCCESSFULLY AT ONE TIME." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520039 FLEXOR RTPS GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC N/A 8962620 00827002130814

    Patients

    Seq Age Sex Outcome Treatment
    1