BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGW .018 SV INTER 180CM ST

    MDR report key: 5952669 · Received September 15, 2016

    Report

    Report Number
    1016427-2016-00079
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 12, 2016
    Report Date
    January 24, 2017
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL 3500A MEDWATCH REPORT WAS SUBMITTED IN A PREVIOUS SYSTEM UNDER REPORT # 1016427-2016-00029. ALL FURTHER REPORTS FOR THIS COMPLAINT WILL BE SUBMITTED UNDER THIS CURRENT REPORT. THE DEVICE IS AVAILABLE TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: A PGW .018 SV INTER 180CM ST WIRE ARE UNWINDED AND BROKE OFF IN THE PATIENT. NO INJURY WAS REPORTED. THE DOCTOR WAS HAVING PROBLEMS WITH GETTING ACCESS AND TRYING TO GET TO A PLACE IN THE HEART WITH THIS WIRE. IT CURLED AND BROKE OFF AT THE TIP. THE TIP DID NOT BREAK OFF IN THE PATIENT. THE DEVICE INVOLVED WITH THE COMPLAINT WAS NOT RETURNED FOR ANALYSIS. FOURTEEN STERILE UNITS OF PGW .018 SV INTER 180CM ST WERE RECEIVED IN ITS ORIGINAL PROPERLY SEALED INNER PACKAGE. PER VISUAL ANALYSIS OF THE RECEIVE UNITS, NO ANOMALIES OR DAMAGES WERE FOUND. THE TIP COIL SECTION WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES OR FRACTURES WERE FOUND. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 503658 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿GUIDEWIRE - FRACTURED-SEPARATED - IN PATIENT¿ AND ¿GUIDEWIRE- UNRAVELED/STRETCHED - IN PATIENT¿ WERE NOT CONFIRMED BASED ON THE PRODUCT ANALYSES OF THE STERILE PRODUCTS, AND THE COMPLAINT PRODUCT WAS NOT RETURNED. THE EXACT CAUSE OF THE ISSUE REPORTED COULD NOT BE DETERMINED. THE FLEXIBLE, DELICATE NATURE OF THE FLOPPY GUIDEWIRE TIP CONFIGURATION REQUIRES DUE CARE IN HANDLING AND USE, AS DIRECTED IN THE DEVICE INSTRUCTIONS FOR USE. REFERENCING THE PRODUCT INSTRUCTIONS FOR USE (IFU), GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR BENDS OR KINKS. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. DAMAGE WILL PREVENT THE GUIDEWIRE FROM PERFORMING WITH ACCURATE TORQUE RESPONSE AND CONTROL. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSES OF THE STERILE DEVICES SUGGEST THAT THE EVENT EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    PRODUCTS WERE RETURNED FOR THIS COMPLAINT. THE ENGINEERING REPORT OF THE PRODUCTS ARE NOT AVAILABLE AT THIS TIME, HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, A PGW .018 SV INTER 180CM ST WIRE ARE UNWINDED AND BROKE OFF IN THE PATIENT. NO INJURY WAS REPORTED. ADDENDUM 8/25/2016: THE DOCTORS HAVING PROBLEMS WITH GETTING ACCESS AND TRYING TO GET TO A PLACE IN THE HEART WITH THESE WIRES. THEY HAVE BEEN CURLING AND BREAKING OFF AT THE TIP. THE TIP IS NOT BREAKING OFF IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606000 PGW .018 SV INTER 180CM ST WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION 503658 35229129

    Patients

    Seq Age Sex Outcome Treatment
    1