BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER PLUS

    MDR report key: 2208778 · Received August 12, 2011

    Report

    Report Number
    1016427-2011-00075
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE SGW .014 STABILIZER 300CM GUIDEWIRE ((B)(4)) WAS REMOVED FROM THE DISPENSER, THE DISTAL COIL WAS FOUND UNRAVELED AT THE CONNECTION OF THE PTFE SLEEVE. AFTER THE COMPLAINT DEVICE WAS CHANGED TO ANOTHER NEW ONE (SAME SIZE, LOT UNK), THE TARGET LESION WAS PRE-DILATED WITH JACKAL (4X20, SJM) AND SMART CONTROL ((B)(4), LOT UNK) WAS PLACED SUCCESSFULLY. THE LESION WAS POST-DILATED WITH CONQUEST (6X20, MEDICON) AND THE PROCEDURE WAS COMPLETED WITHOUT OTHER PROBLEM. THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS. DURING REMOVAL FROM THE PLASTIC HOOP, THE GUIDEWIRE WAS NOT REMOVED FROM THE DISTAL FLOPPY TIP, AND THERE WERE NO ISSUES DURING REMOVAL FROM THE PLASTIC HOOP THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE TARGET SITE WAS THE LEFT SUBCLAVIAN WITH HEAVY CALCIFICATION AND MILD VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 99%. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NON-STERILE SGW .014 STABILIZER 300CM WAS RECEIVED COILED INTO A PLASTIC BAG. THE GUIDEWIRE PRESENTED SEVERAL KINKS, AND IT WAS NOTED THAT THE DISTAL TIP PRESENTED AN UNRAVELED/STRETCHED CONDITION ON DISTAL END. THE UNIT WAS INSPECTED UNDER MICROSCOPE AND THE DAMAGES WERE CONFIRMED. (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10008993. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. THE COMPLAINT REPORTED BY THE CUSTOMER AS 'GUIDEWIRE - UNRAVELED/STRETCHED' WAS CONFIRMED DURING ANALYSIS; HOWEVER THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT. THE KINKS CONDITIONS FOUND ON THE GUIDEWIRE DURING THE ANALYSIS COULD BE RELATED TO COILED CONDITION OF THE PRODUCT WHEN IT IS SHIPPED TO ANALYSIS. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE GUIDEWIRE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT REPORTED BY THE CUSTOMER AS 'GUIDEWIRE - UNRAVELED/STRETCHED' WAS CONFIRMED DURING ANALYSIS; HOWEVER THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    WHEN THE SGW .014 STABILIZER 300CM GUIDEWIRE ((B)(4)) WAS REMOVED FROM THE DISPENSER, THE DISTAL COIL WAS FOUND ALREADY UNRAVELED AT THE CONNECTION OF THE PTFE SLEEVE. AFTER THE COMPLAINT DEVICE WAS CHANGED TO ANOTHER NEW ONE (SAME SIZE, LOT UNK), THE TARGET LESION WAS PRE-DILATED WITH JACKAL (4X20, SJM) AND SMART CONTROL (C10030SL, LOT UNK) WAS PLACED SUCCESSFULLY. THE LESION WAS POST-DILATED WITH CONQUEST (6X20, MEDICON) AND THE PROCEDURE WAS COMPLETED WITHOUT OTHER PROBLEM. THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS. DURING REMOVAL FROM THE PLASTIC HOOP, THE GUIDEWIRE WAS NOT REMOVED FROM THE DISTAL FLOPPY TIP, AND THERE WERE NO ISSUES DURING REMOVAL FROM THE PLASTIC HOOP THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE TARGET SITE WAS THE LEFT SUBCLAVIAN WITH HEAVY CALCIFICATION AND MILD VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS 99%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER PLUS CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70411538

    Patients

    Seq Age Sex Outcome Treatment
    1