BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT

    MDR report key: 2982787 · Received February 28, 2013

    Report

    Report Number
    1016427-2013-00023
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 7, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TIP OF THE PGW .018 SV SHORT 300CM ST GUIDEWIRE UNRAVELED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT. THE COMPLAINT PRODUCT WAS NOT RE-STERILIZED OR RE-SHAPED. THE PRODUCT WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE REPORTED PRODUCT ISSUE. THE TARGET LESION WAS REPORTED TO BE A 50% STENOSED AND CALCIFIED. A DRILLING OR JACK-HAMMER TECHNIQUE WAS NOT USED. THE PRODUCT ISSUE OCCURRED MID-WAY THROUGH THE PROCEDURE. THE DISTAL WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO TRACKING DIFFICULTY NOTED. THE WIRE DID NOT BEHAVE NORMALLY; IT DID NOT HAVE A GOOD TORQUE RESPONSE. THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN DEVICES DURING INSERTION OR WITHDRAWAL, AND THE WIRE DID NOT KINK DURING USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WAS NOTED TO BE FRACTURED WHEN ANALYZED. A NON-STERILE UNIT OF PGW .018 SV SHORT 300CM ST WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. A GUIDE WIRE WAS RECEIVED AND THE COIL SECTION WAS OBSERVED ENTANGLED IN THE BODY OF IT. A BENT CONDITION WAS OBSERVED AT 74 CM AND A KINK CONDITION WAS OBSERVED AT 158CM FROM PROXIMAL TIP. AN UNRAVELED/STRETCHED CONDITION WAS OBSERVED IN DISTAL TIP SECTION. THE GUIDE WIRE WAS INSPECTED VISUALLY AND THE CORE WIRE IN THE DISTAL TIP SECTION WAS OBSERVED FRACTURED. A SEM ANALYSIS WAS REQUIRED IN ORDER TO DETERMINE THE CAUSE OF FRACTURED AND THE RESULTS SHOWED THAT "THE CORE WIRE PRESENTED EVIDENCE OF SMEARING AND REVERSE BENDING. REVERSE BENDING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS; HOWEVER, THE EXACT CAUSE OF THE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. CUTTING AS THE ROOT CAUSE WAS DISCARDED SINCE THE FRACTURE SITE DID NOT PRESENT ANY CHARACTERISTICS TYPICAL OF THIS FAILURE MODE". THE DEVICE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE REPORTED BY THE CUSTOMER AS "DISTAL TIP/ UNRAVELED/STRETCHED-IN PATIENT" WAS CONFIRMED DUE TO THE RECEIVED CONDITION OF THE DEVICE, ALSO A FRACTURED, KINK AND BEND WERE CONFIRMED DURING ANALYSIS. THE EXACT CAUSE OF THESE CONDITIONS COULD NOT BEEN CONCLUSIVELY DETERMINED; HOWEVER, BASED ON THE EVENT DESCRIPTION AND SEM ANALYSIS RESULTS (REVERSE BENDING) AND PROCEDURAL FACTORS (TORQUING DIFFICULTY) MIGHT HAVE CONTRIBUTED TO THESE ISSUES. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALY. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE TIP OF THE PGW .018 SV SHORT 300CM ST GUIDEWIRE UNRAVELED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT. THE COMPLAINT PRODUCT WAS NOT RE-STERILIZED OR RE-SHAPED. THE PRODUCT WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE REPORTED PRODUCT ISSUE. THE TARGET LESION WAS REPORTED TO BE: A 50% STENOSIS, CALCIFIED, NOT TORTUOUS, NOT A BIFURCATION LESION, AND NOT A CHRONIC TOTAL OCCLUSION/CTO. A DRILLING OR JACK-HAMMER TECHNIQUE WAS NOT USED. THE PRODUCT ISSUE OCCURRED MID-WAY THROUGH THE PROCEDURE. THE DISTAL WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO TRACKING DIFFICULTY NOTED. THE WIRE DID NOT BEHAVE NORMALLY, HAVE GOOD TORQUE RESPONSE. THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN DEVICES DURING INSERTION OR WITHDRAWAL. THE WIRE DID NOT KINK DURING USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85870 PGW .018 SV SHORT ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70611501

    Patients

    Seq Age Sex Outcome Treatment
    1