BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 9074395 · Received September 17, 2019

    Report

    Report Number
    3002808486-2019-01489
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    August 30, 2019
    Report Date
    June 23, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# PR276978 INVESTIGATION CONCLUDED THAT THE EVENT COULD NOT LEAD TO A SEROIUS INJURY. THEREFORE THIS EVENT IS CONSIDERED NOT REPORTABLE IN US. H11) MANUFACTURING AND EXPIRATION DATE WAS FILLED BY MISTAKE AND SHOULD BE DELETED. SUMMARY OF INVESTIGATIONAL FINDINGS: WIRE WAS "CHEWED¿. IT IS ASSUMED, THAT WIRE WAS "CHEWED¿ MEANS ELONGATED, KINKED OR DAMAGED IN AT SIMILAR WAY. NO HARM REPORTED. THE INVESTIGATION IS BASED ON THE EVENT DESCRIPTION. NO PRODUCT RETURNED. BASED ON THE LIMITED INFORMATION MADE AVAILABLE FOR US, IT WOULD BE INAPPROPRIATE TO SPECULATE ON WHAT HAVE CAUSED THE EXPERIENCED EVENT, BUT E.G. INCOMPATIBLE OR DEFECT EXCHANGE DEVICE USED OR DAMAGES TO THE WIRES DURING E.G. ALTERING THE TIP FIGURATION COULD CAUSE OR CONTRIBUTE TO THIS KIND OF THE EVENT. ACCORDING TO THE PRODUCT EVALUATION OF THE RETURNED ELSE (PR276331) A DAMAGE WAS FOUND ON THE ELSE, WHICH COULD EXPLAIN THE DIFFICULTY EXPERIENCED IN THE PROCEDURE. HOW SUPPLIED IN THE IFU STATES: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. DO NOT USE THE DEVICE IF DAMAGE HAS OCCURRED. PRECAUSIONS IN THE IFU STATES: ALTERING THE TIP CONFIGURATION OF THE WIRE GUIDE MAY RESULT IN DAMAGE. AS LOT# IS UNKNOWN THE DEVICE HISTORY RECORD CAN NOT BE REVIEWED. AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION, COOK REVIEWED THE DEVICE MASTER RECORD CURRENTLY IN EFFECT FOR TS(C)MG DEVICES AND NO CONTROLS IN THE QC INSTRUCTIONS WERE FOUND CONCERNING THIS ISSUE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SIMILAR TO DEVICE UNDER PMA/510(K) K171513. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "ONCE THEY PUT THE WIRE UP, THEY COULD NOT GET THE DELIVERY SYSTEM IN. THEY PULLED THE WIRE OUT AND THE WIRE LOOKED CHEWED UP. THEY TRIED TO USE ANOTHER WIRE AND IT STILL WOULD NOT WORK. IT SEEMED THERE WAS SOMETHING IN THE DELIVERY SYSTEM THAT WAS HINDERING THE WIRE. THE PHYSICIAN PULLED THE GREY SHEATH BACK. HE CUT THE BLUE INTRODUCER SHEATH. THE PHYSICIAN USED THE COOK GRAFT DELIVERY SYSTEM AS A SHEATH FOR WIRE EXCHANGE. HE PUT IN AN 11 FR SHORT SHEATH AND WIRE. HE PULLED OUT THE REST OF THE COOK SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A GRAFT FROM ANOTHER MANUFACTURER." PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868655 UNKNOWN DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR