BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 3383459 · Received October 3, 2013

    Report

    Report Number
    9616099-2013-00621
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    September 10, 2013
    Report Date
    September 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USE OF A SAVVY BALLOON THE BALLOON AND DELIVERY CATHETER SEPARATED DURING A PELVIC ANGIOPLASTY PROCEDURE. ONCE THE EXPANSION OF THE VESSEL WAS COMPLETE, ¿THE FLASK AND ITS DELIVERY CATHETER WERE SEPARATED DURING WITHDRAWAL¿. A 4 FR INTRODUCER (BRAND UNKNOWN) WAS USED DURING THE WITHDRAWAL. PLEASE NOTE THAT MULTIPLE ATTEMPTS TO GATHER ADDITIONAL PATIENT AND PROCEDURAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED BALLOON WITHDRAWAL DIFFICULTY AND SEPARATION COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. WITH THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED SEPARATION COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED ON NOVEMBER 21, 3013. THE BALLOON OF THE DEVICE IS DETACHED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION UPDATED TO REFLECT ANALYSIS OF THE RETURNED DEVICE. DURING USE OF A SAVVY BALLOON THE BALLOON AND DELIVERY CATHETER SEPARATED DURING A PELVIC ANGIOPLASTY PROCEDURE. ONCE THE EXPANSION OF THE VESSEL WAS COMPLETE, ¿THE FLASK AND ITS DELIVERY CATHETER WERE SEPARATED DURING WITHDRAWAL¿. A 4 FR INTRODUCER (BRAND UNKNOWN) WAS USED DURING THE WITHDRAWAL. PLEASE NOTE THAT MULTIPLE ATTEMPTS TO GATHER ADDITIONAL PATIENT AND PROCEDURAL INFORMATION HAVE BEEN UNSUCCESSFUL. ONE NON STERILE SAVVY 6.0MM X 4.0CM WAS RECEIVED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEAR HAVE BEEN INFLATED. THE BALLOON WAS RECEIVED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED SEPARATED OF INNER BODY AND OUTER BODY. THE BALLOON WAS RIPPED SINCE THE INNER BODY AN OUTER BODY SHOWED ELONGATION IN THE SEPARATION AREA. THERE WERE BLOOD RESIDUES OBSERVED IN THE RETURNED DEVICE. UNKNOWN 4F CATHETER SHEATH INTRODUCER WAS RECEIVED WITH RETURNED DEVICE. NO OTHER ANOMALIES WERE OBSERVED WITH RETURNED DEVICE. INSERTION WITHDRAWAL TEST WAS NOT PERFORMED SINCE THE BALLOON WAS RECEIVED SEPARATED OF BODY SHAFT. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF BALLOON SEPARATED. SEM RESULTS SHOW THAT THE BODY EXTERNAL SURFACE PRESENTED EVIDENCE OF ELONGATION AT THE SURROUNDINGS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS. 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 BALLOON SEPARATED REPORTED BY THE CUSTOMER WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE WITHDRAW DIFFICULTY COULD NOT BE CONFIRMED AS INSERTION WITHDRAWAL TESTING COULD NOT BE PERFORMED DUE TO THE SEPARATED CONDITION OF THE RETURNED DEVICE. WITH THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NEITHER THE DHR NOT THE ANALYSIS SUGGESTS THAT THE REPORTED SEPARATION COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    DURING USE OF A SAVVY BALLOON IT WAS REPORTED THAT THE BALLOON AND DELIVERY CATHETER SEPARATED DURING A PELVIC ANGIOPLASTY PROCEDURE. ONCE THE EXPANSION OF THE VESSEL WAS COMPLETE, THE FLASK AND ITS DELIVERY CATHETER WERE SEPARATED DURING WITHDRAW. A 4 FR INTRODUCER (BRAND UNKNOWN) WAS USED DURING THE WITHDRAWAL. PLEASE NOTE THAT MULTIPLE ATTEMPTS TO GATHER ADDITIONAL PATIENT AND PROCEDURAL INFORMATION HAVE BEEN REQUESTED AND HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499150 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15803055

    Patients

    Seq Age Sex Outcome Treatment
    1 4 FR INTRODUCER (BRAND UNKNOWN)