BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGW STAB MARKER .014 180 ST SS

    MDR report key: 2102326 · Received May 25, 2011

    Report

    Report Number
    1016427-2011-00042
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE PACKAGE OF STABILIZER (0.014 ST SS) WAS OPENED AND THE PRODUCT WAS REMOVED FROM THE PROTECTIVE PLASTIC COVERING. WHEN THE PHYSICIAN TRIED TO PRE-SHAPE THE TIP OF THE STABILIZER PRIOR TO INSERTION, HE CONFIRMED THAT THE COILED SHAFT OF THE GUIDE WIRE BECAME ELONGATED AND WAVED. THE GUIDE WIRE WAS EXCHANGED FOR A DIFFERENT STABILIZER, AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS NOT CLINICALLY USED IN THE PATIENT, BUT IT WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE PATIENT'S INFECTIOUS DISEASE. HOWEVER, A PICTURE OF THE STABILIZER WAS ATTACHED. THE PHYSICIAN DID NOT INDICATE OF ANY DIFFICULTY IN REMOVING THE PROTECTIVE PLASTIC COVERING. THE REPORTER INDICATED THAT THE DEVICE APPEARED NORMAL PRIOR TO THE PHYSICIAN TRYING TO PRE-SHAPE THE TIP AND THAT THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. IT WAS UNKNOWN IF THE PHYSICIAN PULLED ON THE TIP WHILE RE-SHAPING. THE IFU INDICATES THAT GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. THE STERILE PACKAGE SHOULD BE OPENED SLOWLY. THE IFU INSTRUCTS THAT "TO PREVENT DAMAGE TO THE DISTAL TIP OF THE GUIDEWIRE AND TO PREVENT THE GUIDEWIRE FROM SPRINGING ONTO A NON-STERILE FIELD, CAREFULLY REMOVE THE GUIDEWIRE FROM THE DISPENSING TUBE. USE THE DISPENSER WINDOW TO ADVANCE THE GUIDEWIRE DISTAL TIP, SUCH THAT THE GUIDEWIRE CAN BE REMOVED BY GRASPING THE COATED SHAFT. NOTE: DO NOT PULL THE DISTAL TIP TO REMOVE GUIDEWIRE FROM DISPENSER AS IT MAY DAMAGE THE TIP. CAUTION: GENTLY INTRODUCE AND ADVANCE THE GUIDEWIRE TO PREVENT DAMAGING THE DISTAL TIP. NOTE: TO AID IN THE NAVIGATION WITHIN AND SELECTION OF ARTERIES, THE GUIDEWIRE MAY BE RESHAPED." NO PRODUCT WAS RETURNED FOR EVALUATION; ONLY A PICTURE WAS RECEIVED TO BE EVALUATED. THE PICTURE SHOWS WHAT APPEARS TO BE AN SGW STAB MARKER (B)(4). THE PICTURE SHOWS THAT THE COIL TIP HAS A STRETCHED SECTION AND A BENT CONDITION. IT WAS ALSO NOTED THAT THE COIL HAS A WAVY SECTION. NO OTHER DAMAGES WERE NOTED AT THE PROVIDED PICTURE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425242. THIS PACKAGING LOT CONTAINED 175 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON AUGUST 12, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURE BY THE CUSTOMER AS "DISTAL TIP- UNRAVELED/STRETCHED-DURING PREP" WAS CONFIRMED ACCORDING TO THE OBSERVATIONS MADE TO THE PROVIDED PICTURE; HOWEVER, THE CAUSE OF THIS DAMAGE AND THE OTHER DAMAGES OBSERVED ON THE PICTURE COULD NOT BE CONCLUSIVELY DETERMINED. THE DAMAGES DO NOT APPEAR TO BE MANUFACTURING RELATED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW AND WITHOUT THE PRODUCT AVAILABLE FOR EVALUATION AND ANALYSIS, IT IS NOT POSSIBLE TO DRAW A RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, THERE ARE POSSIBLE PROCEDURAL OR HANDLING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT AS THERE WAS NO PRODUCT ANOMALY NOTED DURING REMOVAL AND INSPECTION OF DEVICE PRIOR TO THE ATTEMPT TO RE-SHAPE THE TIP. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PACKAGE OF STABILIZER (0.014 ST SS) WAS OPENED AND THE PRODUCT WAS REMOVED FROM THE PROTECTIVE PLASTIC COVERING. WHEN THE PHYSICIAN TRIED TO PRE-SHAPE THE TIP OF THE STABILIZER PRIOR TO INSERTION, HE CONFIRMED THAT THE COILED SHAFT OF THE GUIDE WIRE BECAME ELONGATED AND BE WAVED. THE GUIDE WIRE WAS EXCHANGED FOR A DIFFERENT STABILIZER, AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGW STAB MARKER .014 180 ST SS CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70710827

    Patients

    Seq Age Sex Outcome Treatment
    1