BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 9823336 · Received March 12, 2020

    Report

    Report Number
    1820334-2020-00594
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 24, 2020
    Report Date
    August 11, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002438705
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INITIAL REPORT. AS INITIALLY REPORTED, DURING A NEPHRECTOMY, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET "SHREDDED". THE WIRE REPORTEDLY BECAME STUCK IN THE NEEDLE AND SUBSEQUENTLY SEPARATED. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH 3500A ON 06MAR2020. THE PROCEDURE WAS A LAPAROSCOPIC HAND ASSISTED LEFT RADICAL NEPHRECTOMY. WHILE ATTEMPTING TO GAIN LARGE BORE VENOUS ACCESS IN THE RIGHT ANTECUBITAL SPACE, THE NEEDLE WAS SUCCESSFULLY PLACED; HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE WIRE GUIDE WAS THREADED INTO THE VEIN. REPORTEDLY, AS THE WIRE GUIDE WAS PULLED, IT APPEARED TO SHEAR AND WAS FRAYED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER. A VASCULAR CONSULT WAS OBTAINED TO VIEW FLUOROSCOPIC IMAGES IN ORDER TO CONFIRM THERE WERE NO FRAGMENTS IN THE PATIENT. THE ORIGINAL SURGERY WAS COMPLETED. 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. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE EVIDENCE INDICATES THE PRODUCT WAS MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. NO GAPS WERE DISCOVERED IN THE MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, DRAWING, OR QUALITY CONTROL PROCEDURES FOR THIS DEVICE. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. AN IFU IS PROVIDED WITH THE DEVICE, WHICH STATES ¿INSERT THE NEEDLE INTO THE VESSEL. WARNING: 1. PLACE A FINGER OVER THE HUB OF THE NEEDLE TO MINIMIZE BLOOD LOSS AND THE RISK OF AIR ASPIRATION. 2. ADVANCE THE .018 INCH WIRE GUIDE THROUGH THE INTRODUCER NEEDLE. CAUTION: DO NOT WITHDRAW THE WIRE GUIDE THROUGH THE INTRODUCER NEEDLE; BREAKAGE MAY RESULT. IF THE WIRE GUIDE TIP MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND THE WIRE AS A UNIT. 3. WITHDRAW THE INTRODUCER NEEDLE, LEAVING THE WIRE GUIDE IN PLACE." BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED, HOWEVER THERE WAS NO EVIDENCE TO SUGGEST THAT MANUFACTURING ISSUES CAUSED THIS FAILURE. IT IS POSSIBLE THAT PATIENT ANATOMY MAY HAVE BEEN A CONTRIBUTING FACTOR IN THIS FAILURE HOWEVER, NO DETAILS WERE PROVIDED. NO FURTHER ESCALATION HAS BEEN DEEMED NECESSARY AT THIS TIME. 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.

    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

    PER THE INITIAL REPORTER, THE DEVICE IS NOT AVAILABLE FOR RETURN. PER MEDWATCH 3500A, THE DEVICE IS AVAILABLE. CLARIFICATION HAS BEEN REQUESTED. PMA/510(K) NUMBER = K171275. 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

    INITIALLY REPORTED, DURING A NEPHRECTOMY, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET "SHREDDED". THE WIRE REPORTEDLY BECAME STUCK IN THE NEEDLE AND SUBSEQUENTLY SEPARATED. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH 3500A ON 06MAR2020. THE PROCEDURE WAS A LAPAROSCOPIC HAND ASSISTED LEFT RADICAL NEPHRECTOMY. WHILE ATTEMPTING TO GAIN LARGE BORE VENOUS ACCESS IN THE RIGHT ANTECUBITAL SPACE, THE NEEDLE WAS SUCCESSFULLY PLACED; HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE WIRE GUIDE WAS THREADED INTO THE VEIN. REPORTEDLY, AS THE WIRE GUIDE WAS PULLED, IT APPEARED TO SHEAR AND WAS FRAYED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER. A VASCULAR CONSULT WAS OBTAINED TO VIEW FLUOROSCOPIC IMAGES IN ORDER TO CONFIRM THERE WERE NO FRAGMENTS IN THE PATIENT. THE ORIGINAL SURGERY WAS COMPLETED. 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
    289565 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G43870 9972043 00827002438705

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR