BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 12710778 · Received October 28, 2021

    Report

    Report Number
    3002808486-2021-01931
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    April 13, 2021
    Report Date
    October 28, 2021
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). OCCUPATION: NON-HEALTHCARE PROFESSIONAL. REFERRED TO AS DIRECTOR. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K171513 SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER COMPLETING THE PROCEDURE THE WIRE GUIDE ¿STRIPPED¿ DURING REMOVAL. THE WIRE GUIDE WAS RETURNED INSIDE THE HOLDER. THE INSERTER WAS STILL LOCKED TO THE HOLDER, BUT THE BOTTOM CAP WAS NOT RETURNED. CLOSE TO THE DISTAL TIP THE WIRE GUIDE WAS SEVERELY ELONGATED AND MANDRIL AS WELL AS GOLD COIL HAD FRACTURED. HOWEVER, REMNANTS OF BOTH MANDRIL AND GOLD COIL WERE NOTED INSIDE THE DISTAL WELDING THUS INDICATING A PROPER FIXATION. BASED ON THESE FINDINGS THE EXACT REASON FOR THE WIRE GUIDE TO ELONGATE/FRACTURE DURING REMOVAL CANNOT BE DETERMINED, BUT SINCE REPORTED THAT ¿EVERYTHING WERE HARD TO PUSH INTO THE ARTERIES FROM THE BEGINNING¿, THE WIRE GUIDE MAY HAVE BEEN SOMEHOW DAMAGED DURING ALTERATION PRIOR TO USE OR DURING THE DIFFICULT ADVANCEMENT AND IF SO, THE DAMAGE MAY HAVE CAUSED THE RESISTANCE FELT DURING REMOVAL AND RESULTED IN THE FRACTURE. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2021: AFTER CHECKING THE LAST CONTROL ANGIOGRAPHY WAS GOOD, SURGEONS PULLED OUT EVERY ACCESSORY, WHEN THEY PULLED OUT THE LUNDERQUIST DOUBLE CURVED (UNDER RADIOSCOPY BUT NOT INTO A CATHETER), THEY FELT A RESISTANCE AND THEN A RELEASE LIKE THE DEVICE HAD BEEN BROKEN. THEY CHECKED THEY PULLED OUT THE PROXIMAL ATRAUMATIC TIP OF THE LUNDERQUIST, CONSIDERING THEY PULLED EVERY PART OF THE PRODUCT OUT OF THE PATIENT, THEY FINISHED THE PROCEDURE SUTURING WITH THE PROGLIDE SYSTEMS. LUNDERQUIST DOUBLE CURVED "STRIPPED" DURING SURGERY WHEN SURGEONS PULLED IT OUT. EVEN THE PIGTAIL¿S MARKERS MOVED. THEY ARE 20 GOLD MAKERS AND 13 OF THEM WERE ALL DISLOCATED OF THEIR PLACES AND WENT UP TO THE 8TH GOLD MARKER. IT WAS NOTICED, THAT WIRE GUIDES, CATHETERS (PIGTAIL AND SELECTIVE ONE), LUNDERQUISTS, DELIVERY SYSTEMS OF GRAFTS, EVERYTHING WERE HARD TO PUSH INTO THE ARTERIES FROM THE BEGINNING (SPECIALLY ON THE LEFT SIDE). THE PIGTAIL CATHETER MENTIONED IS A CORDIS PRODUCT, NOT COOK. EVERYTHING EXCEPT THIS EVENT WENT VERY WELL DURING THE PROCEDURE PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610857 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR