BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 7389346 · Received April 2, 2018

    Report

    Report Number
    1820334-2018-00836
    Event Type
    Injury
    Date Received
    April 2, 2018
    Date of Event
    March 20, 2018
    Report Date
    June 20, 2018
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002355507
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE SHAFT WAS SEPARATED AT A DISTANCE OF 2.1 CM DISTAL TO THE HUB. THE SEPARATED SEGMENT WAS MEASURED TO BE 7.6 CM IN LENGTH. THE SEPARATED SEGMENT HAD A 20 DEGREE BEND THAT BEGAN APPROXIMATELY 3 CM FROM THE POINT OF SEPARATION. THE INNER DILATOR WAS RECEIVED WITH THE WIRE GUIDE INSERTED IN THE DILATOR. THE DILATOR EXHIBITED A 15 DEGREE BEND THAT BEGAN APPROXIMATELY 9.5 CM FROM THE PROXIMAL HUB. THE DILATOR WAS MEASURED TO BE 11.4 CM IN LENGTH. THERE WAS NO ADDITIONAL DAMAGE NOTED TO THE DILATOR. 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. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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.

    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. REFER TO SECTION H10 FOR INVESTIGATIONAL FINDINGS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) NUMBER = K133114. 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 THAT THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED INTO TWO PARTS DURING AN AXILLARY BI-FEMORAL BYPASS PROCEDURE. THE SHEATH AND DILATOR WERE INSERTED OVER THE WIRE INTO THE AXILLARY ACCESS SITE. REPORTEDLY, THIS SITE WAS NEITHER SIGNIFICANTLY SCARRED NOR CALCIFIED. THE MICROPUNCTURE WIRE AND DILATOR WERE REMOVED AND A SHORT BENSON WIRE WAS INSERTED. WHILE THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET WAS BEING REMOVED, IT SEPARATED INTO TWO PARTS. THE TWO PARTS WERE RETRIEVED OVER THE .035 GUIDEWIRE SHEATH USING FORCEPS. A SHORT SHEATH WAS PUT IN PLACE AND AN ANGIOPLASTY WAS SUCCESSFULLY COMPLETED RESULTING IN A SIGNIFICANT IMPROVEMENT IN PATENCY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND, 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
    231637 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC 00827002355507

    Patients

    Seq Age Sex Outcome Treatment
    1