BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 2232384 · Received September 2, 2011

    Report

    Report Number
    9616099-2011-00703
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE PHYSICIAN HAD DIFFICULTY WITHDRAWING THE 110 CM. OPTA PRO 7 X 8 BALLOON CATHETER THROUGH THE UNKNOWN CATHETER SHEATH INTRODUCER (CSI). THE PHYSICIAN REMOVED BOTH THE SHEATH AND THE BALLOON CATHETER TOGETHER. THERE WAS NO REPORTED PATIENT INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PRODUCT WAS RETURNED FOR INSPECTION. A NON STERILE OPTA PRO 7X8 110 CM WAS RECEIVED COILED AND INSIDE A BAG. THE UNIT WAS INSERTED IN A NON-CORDIS SHEATH INTRODUCER WITH A METALLIC BODY SHAFT. BALLOON WAS PREVIOUSLY INFLATED. DRIED BLOOD RESIDUES WERE NOTED ALONG THE CATHETER AND AT THE DISTAL SECTION OF THE METALLIC SHEATH INTRODUCER. THE LEAKAGE FUNCTIONAL TEST FOR THE BALLOON PER (B)(4) WAS PERFORMED AND BALLOON WAS INFLATED AND DEFLATED WITHOUT ANY ANOMALIES. THE PROXIMAL SEAL COULD NOT BE MEASURED SINCE THE UNIT IS STOCKED IN THE NON-CORDIS SHEATH INTRODUCER. THE DEVICE WAS SUBMITTED TO ULTRASONIC AND HOT WATER BUT THE ATTEMPTS TO RETRIEVE THE DEVICE FORM THE SHEATH INTRODUCER WERE NOT SUCCESSFUL. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED PTA WITHDRAWAL DIFFICULTY WAS CONFIRMED, THE EXACT CAUSE OF THE FAILURE REPORTED COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER; PROCEDURAL FACTORS COULD HAVE CONTRIBUTE TO THE REPORTED FAILURE. CONTROLS ARE PLACED IN THE PRODUCTION LINES TO INSPECT PROXIMAL SEAL WITH A GO/NO GO GAGE, REFER TO (B)(4). NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURES EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY DEVICE INTERACTION.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE PHYSICIAN HAD DIFFICULTY WITHDRAWING THE 110 CM. OPTA PRO 7 X 8 BALLOON CATHETER THROUGH THE UNKNOWN CATHETER SHEATH INTRODUCER (CSI). THE PHYSICIAN REMOVED BOTH THE SHEATH AND THE BALLOON CATHETER TOGETHER. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15344777

    Patients

    Seq Age Sex Outcome Treatment
    1