BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER PLUS

    MDR report key: 2257247 · Received September 21, 2011

    Report

    Report Number
    1016427-2011-00087
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING USE THE SGW STAB PLUS WIRE KINKED AND UNRAVELED/STRETCHED. DURING AN ANGIOPLASTY IT WAS NOTICED THAT THE SGW STAB PLUS .014 180CM J SS KINK AT THE MIDDLE. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING PRIOR TO USE. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE AT ANY TIME DURING THE PROCEDURE. A BMW WIRE WAS USED TO COMPLETE THE PROCEDURE. UPON RECEIPT, THE PRODUCT ANALYSIS REPORTED THE PROXIMAL SECTION OF THE COIL TIP WAS STRETCHED. THE ACCOUNT CONFIRMED THE STRETCHED SECTION OF THE COIL TIP OCCURRED DURING THE PROCEDURE. DESPITE MULTIPLE ATTEMPTS NO FURTHER INFORMATION HAS BEEN AVAILABLE TO DATE. THERE WAS NO REPORT OF INJURY TO THE PATIENT. ONE NON-STERILE STABILIZER PLUS WAS RECEIVED COILED IN A PLASTIC BAG. THE GUIDEWIRE WAS FOUND KINKED AND THE COIL TIP WAS FOUND WAVY. NO OTHER ANOMALIES WERE NOTED. COIL TIP WAS OBSERVED UNDER THE MICROSCOPE AND IT WAS NOTED THAT THE PROXIMAL SECTION WAS STRETCHED. NO OTHER ANOMALIES WERE NOTED APART FROM THE ONES PREVIOUSLY MENTIONED. (B)(4). THE FAILURE REPORTED BY THE CUSTOMER AS 'GUIDEWIRE KINKED/BENT' WAS CONFIRMED DURING VISUAL ANALYSIS. A KINK WAS FOUND ON THE GUIDEWIRE AND THE CAUSE OF THE DAMAGES FOUND ON THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED. 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 RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT OF WIRE KINK AND UNRAVELED/STRETCHED WERE CONFIRMED ON ANALYSIS; HOWEVER, THE EXACT CAUSE OF THE CONFIRMED FAILURES COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. REVIEW OF THE VERY LIMITED INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENTS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE ANALYSIS WAS COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. ONE NON-STERILE STABILIZER PLUS WAS RECEIVED COILED IN A PLASTIC BAG. THE GUIDEWIRE WAS FOUND KINKED AND THE COIL TIP WAS FOUND WAVY. NO OTHER ANOMALIES WERE NOTED. THE COIL TIP WAS OBSERVED UNDER THE MICROSCOPE AND IT WAS NOTED THAT THE PROXIMAL SECTION WAS STRETCHED. NO OTHER ANOMALIES WERE NOTED APART FROM THE ONES PREVIOUSLY MENTIONED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424547. THIS PACKAGING LOT CONTAINED 250 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON JULY 22, 2010. THE 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 "GUIDEWIRE KINKED/BENT" WAS CONFIRMED. DURING VISUAL ANALYSIS A KINK WAS FOUND ON THE GUIDEWIRE. THE CAUSE OF THE DAMAGES FOUND ON THE UNIT COULD NOT BE CONCLUSIVELY DETERMINED; 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 RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE QUALRAP CONFIRMED THE STRETCHED SECTION OF THE COIL TIP OCCURRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    DURING AN ANGIOPLASTY, IT WAS NOTICED THAT THE SGW STAB PLUS .014 180CM J SS KINKED AT THE MIDDLE. THE DEVICE WAS STORED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE NOTED WITH THE PACKAGING PRIOR TO USE. NO EXCESSIVE FORCE WAS USED WITH THE DEVICE AT ANY TIME DURING THE PROCEDURE. A BMW WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE PRODUCT ANALYSIS REPORTED THE PROXIMAL SECTION OF THE COIL TIP WAS STRETCHED. THEREFORE, THE COMPLAINT WAS UPDATED TO CAPTURE UNRAVELED/STRETCHED AS A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER PLUS CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70710727

    Patients

    Seq Age Sex Outcome Treatment
    1