BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV SHORT

    MDR report key: 2618252 · Received June 15, 2012

    Report

    Report Number
    1016427-2012-00083
    Event Type
    Malfunction
    Date Received
    June 15, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 30, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE DISTAL TIP OF THE PGW SV SHORT 300 CM. ST GUIDEWIRE UNRAVELED WHILE INSIDE THE PATIENT. THE GUIDEWIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE PGW .018 SV SHORT WAS RECEIVED COILED IN A PLASTIC BAG; ADDITIONALLY OTHER 7 STERILE GUIDEWIRES WERE RECEIVED IN TWO BOXES (2 IN ONE BOX AND 5 IN THE OTHER ONE). THE NON-STERILE GUIDEWIRE WAS FOUND BENT AT 173CM FROM PROXIMAL END ALSO THE COIL TIP WAS FOUND DAMAGED, IT WAS KINKED AND UNRAVELED/STRETCHED. FROM THE STERILE UNITS 2 SAMPLES WERE INSPECTED AND NO ANOMALIES WERE FOUND. COIL TIP OF THE NON-STERILE GUIDEWIRE WAS OBSERVED UNDER THE MICROSCOPE AND DAMAGES WERE CONFIRMED, COIL TIP WAS KINKED AND UNRAVELED AND STRETCHED APPARENTLY EXCESSIVE FORCE WAS USED ON THE UNIT. THE OTHER 2 STERILE GUIDEWIRES WERE ALSO INSPECTED BUT NO ANOMALIES WERE FOUND. (B)(4). THE IFU WARNS TO NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. FIRST, USING FLUOROSCOPY, DETERMINE THE CAUSE OF RESISTANCE AND TAKE ANY NECESSARY REMEDIAL ACTION. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE, AND/OR GUIDEWIRE TIP SEPARATION, OR DIRECT DAMAGE TO THE VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED (VIA FLUOROSCOPY) BY NOTING ANY BUCKLING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR. IN ADDITION, 'IF ANY RESISTANCE IS FELT, I.E., DUE TO VESSEL SPASM, BENT GUIDEWIRE, OR GUIDEWIRE ENTRAPMENT, WHILE MANIPULATING OR REMOVING THE GUIDEWIRE IN THE BLOOD VESSEL: STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. USING FLUOROSCOPY, FIRST DETERMINE THE CAUSE OF THE RESISTANCE, THEN TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED. THE FAILURE REPORTED BY THE CUSTOMER AS 'DISTAL TIP UNRAVELED/STRETCHED' WAS CONFIRMED. THE COIL TIP OF THE NON-STERILE GUIDEWIRE WAS FOUND UNRAVELED/STRETCHED, HOWEVER THE ANALYSIS AND THE DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. THE CAUSE OF THE DAMAGES FOUND ON UNIT COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, PROCEDURAL FACTORS OR HANDLING MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION SINCE THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE ACTION 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 DISTAL TIP OF THE PGW SV SHORT 300 CM. ST GUIDEWIRE UNRAVELED WHILE INSIDE THE PATIENT. THE GUIDEWIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PGW .018 SV SHORT ENDOVASCULAR WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70212442

    Patients

    Seq Age Sex Outcome Treatment
    1