BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE

    MDR report key: 7050268 · Received November 21, 2017

    Report

    Report Number
    1820334-2017-04240
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 10, 2017
    Report Date
    March 13, 2018
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002046481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE MANUFACTURING DOCUMENTS IN PLACE AT THE TIME OF MANUFACTURE WERE REVIEWED AND IT WAS FOUND THAT THE SPRINGINESS OF THE COIL AND THE SECUREMENT OF THE COIL TO THE INNER CORE (MANDREL AND SAFETY WIRE) WAS VISUALLY AND TACTILELY INSPECTED BY QUALITY CONTROL. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WAS ONE OTHER REPORTED COMPLAINT (TIP STRAIGHT INSTEAD OF CURVED) FOR THIS LOT NUMBER. TWO OPENED (ONE USED/ ONE UNUSED) STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDES (LOT NUMBER 8142078) WERE RETURNED WITHOUT PROTECTIVE HOLDERS. ELEVEN UNUSED, UNOPENED WIRE GUIDES (LOT NUMBER 8142078) WERE ALSO RETURNED FOR EVALUATION. THE USED WIRE GUIDE WAS RETURNED IN DAMAGED CONDITION WITH BIOMATTER PRESENT ON THE DISTAL END. A BEND IN THE WIRE WAS PRESENT. DISTAL TO THE BEND, THE COIL FELT UNSUPPORTED, AND THERE WAS MORE COIL ELONGATION THAN EXPECTED WHEN PULLED. THE COIL WAS STRETCHED TO VIEW THE CORE, AND NO WIRE COULD BE VISUALIZED WITHIN THE COIL DISTAL TO THE BEND. THE PRESENCE OF A MANDREL WIRE WAS CONFIRMED, AND THE COIL OVER THIS CORE MANDREL WIRE WAS STRETCHED SUCH THAT THE CORE WIRE WAS VISIBLE BETWEEN THE COILS. THE WIRE OUTER DIAMETER (OD) MEASURED FROM 0.034 TO 0.0345 INCHES WITH SLIGHT VARIABILITY FROM ONE LOCATION TO ANOTHER ALONG THE LENGTH OF THE WIRE. THE UNUSED, OPENED WIRE GUIDE WAS RETURNED IN DAMAGED CONDITION WITHOUT A HOLDER. THERE WAS ONE BEND ROUGHLY 7 CENTIMETERS (CM) FROM DISTAL TIP. THE BEND AT 7 CM WAS BELIEVED TO BE THE BEND IN THE SAFETY WIRE WHICH SHOULD RESIDE AT THE DISTAL TIP. THERE WAS ANOTHER BEND 20 CM FROM DISTAL TIP, LIKELY FROM HANDLING. SIMILAR TO THE USED WIRE, THE COIL WAS MORE EXTENSIBLE AND FELT UNSUPPORTED DISTAL TO THE BEND LOCATED 7 CM FROM THE DISTAL TIP. FOR EACH OF THE 11 UNOPENED, UNUSED WIRES, THE LENGTH OF WIRE THAT EXTENDS OUT OF THE HOLDER WAS MEASURED (EXCEPT ONE AS IT WAS MANIPULATED PRIOR TO MEASURING), AND THE WIRES WERE MANUALLY CHECKED AGAINST SPECIFICATIONS. FOR ALL WIRES, JUNCTION B WELD HAS CAPTURED COIL AND SAFETY WIRE, COIL MOVED FREELY OVER MANDREL, SAFETY WIRE AND SOLDER CONNECTION, AND THERE WAS SLIGHT SPRING IN COILS. ADDITIONALLY, THE FOLLOWING WAS OBSERVED: WIRE GUIDE 2: WHEN THE INSERTER WAS PULLED BACK OFF THE RADIUS OF THE CURVED TIP, IT DID NOT ASSUME THE CORRECT SHAPE. IT FELT AS THOUGH THERE WAS A KINK IN THE SAFETY WIRE 15 MILLIMETERS (MM) FROM THE WELD. WIRE GUIDE 5: WHEN THE INSERTER WAS PULLED BACK, THE TIP REMAINED STRAIGHT. THE PROXIMAL END OF THE WIRE WAS ALSO STRAIGHT. WHEN ATTEMPTING TO SHAPE A CURVE WITH GENTLE FORCE SOMETHING SNAPPED INSIDE OF THE COIL; THE SNAP WAS BELIEVED TO BE THE SAFETY WIRE SEPARATING FROM THE JUNCTION B WELD. WIRE GUIDE 11: WHEN THE INSERTER WAS PULLED BACK THE TIP REMAINED STRAIGHT. THE PROXIMAL END OF THE WIRE WAS ALSO STRAIGHT. WHEN ATTEMPTING TO SHAPE A CURVE WITH GENTLE FORCE SOMETHING SNAPPED INSIDE OF THE COIL; THE SNAP IS BELIEVED TO BE THE SAFETY WIRE SEPARATING FROM THE DISTAL WELD. TO VERIFY THIS, DESTRUCTIVE TESTING WAS PERFORMED. ROUGHLY 15 MM WERE CUT OFF FROM THE DISTAL COIL FOR INVESTIGATION. A PORTION OF THE SAFETY WIRE WAS READILY REMOVED FROM THE PIECE AFTER IT HAD BEEN CUT; CONFIRMING THAT THE SAFETY WIRE RELEASED FROM THE END WELD WHEN THE POP WAS FELT. THE SAFETY WIRE AND WELD BOTH BEHAVE AS THOUGH THEY HAVE BEEN MAGNETIZED. THE THREE UNUSED DEVICES (2,5,11) THAT WERE NOTED TO HAVE A STRAIGHT CONFIGURATION IN THE PACKAGING ARE NOT CONFIRMED TO BE NON-CONFORMING. TO BE CONSIDERED NON-CONFORMING, THE WIRES WOULD NEED TO HAVE BEEN FULLY REMOVED FROM THE PACKAGING AND THEN COMPARED TO THE CURVE TEMPLATE. HOWEVER, DURING INVESTIGATION OF THESE WIRES FOR THE FAILURE REPORTED IN THIS COMPLAINT, THE TIPS WERE MANIPULATED AND IN ONE CASE FOUND TO BE KINKED AND TWO CASES FOUND TO HAVE SEPARATED THE SAFETY WIRE FROM THE SOLDER. DUE TO THIS, WE ARE UNABLE TO PERFORM THE COMPARISON TO THE CURVE TEMPLATE. THESE DEVICES ARE NOT CONFIRMED IN THIS COMPLAINT FOR THE REPORTED FAILURE AND CANNOT BE ASSESSED FURTHER DUE TO MANIPULATION DURING INVESTIGATION. MEASUREMENTS OF THE TWO USED DEVICES IN QUESTION WERE PERFORMED AND IT WAS FOUND THAT THE DEVICES WERE MANUFACTURED TO SPECIFICATION. THE REPORTED FAILURE (CORE WIRE MISSING) COULD NOT BE OBSERVED NOR DUPLICATED. THE RETURNED, UNOPENED DEVICES WERE FOUND TO BE FULLY INTACT WITH APPROPRIATE WELD-SECUREMENT. EVALUATION OF THE RETURNED PRODUCTS WHICH THE CUSTOMER HAD REMOVED FROM THE PACKAGE HAD AN UNSUPPORTED REGION OF COIL AT THE DISTAL TIP DUE TO WELD SEPARATION FROM THE SAFETY WIRE (WELD BEAD REMAINED ATTACHED TO THE COIL); HOWEVER, THE CORE MANDRELS AND SAFETY WIRES WERE PRESENT WITHIN THE OUTER COILS. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THIS EVENT OCCURRED DUE TO THE FOLLOWING: THE WIRE GUIDES MET FORCES IN EXCESS OF INTENDED DESIGN, OR USER TECHNIQUE LED TO DISTAL WELD SEPARATION FROM THE SAFETY WIRE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, WITHDRAWAL OF THE STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE WAS DIFFICULT, AND ELONGATED CREATING A SPRING-LIKE EFFECT. FOLLOWING SUCCESSFUL COMPLETION OF THE PROCEDURE, A STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE WITH THE SAME LOT NUMBER WAS TESTED AND PRESENTED THE SAME MALFUNCTION. ACCORDING TO THE INITIAL REPORTER, NO PORTION OF THE DEVICE SEPARATED AND/OR REMAINED IN THE PATIENT, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829701 STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G04648 00827002046481

    Patients

    Seq Age Sex Outcome Treatment
    1