BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 1932886 · Received December 20, 2010

    Report

    Report Number
    9616099-2010-00999
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 19, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S90
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE PHYSICIAN INFLATED THE 2.50X20 FIRESTAR BALLOON AT 8 ATM, IT COULD NOT BE FURTHER INFLATED. THE PHYSICIAN THEN DEFLATED THE BALLOON; HOWEVER, BLOOD WAS OBSERVED DURING DEFLATION. THEN THE PHYSICIAN WITHDREW THE BALLOON OUTSIDE PATIENT, HE FOUND THE BALLOON WAS RUPTURED WITH A HOLE. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE TARGET LESION LOCATION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS TYPE B. THE RATE OF STENOSIS WAS 85%. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED PRIOR TO USE. A RADIAL APPROACH WAS USED TO ACCESS THE PATIENT. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. THE CONTRAST TO SALINE RATIO USED TO INFLATE THE BALLOON WAS REPORTED AS "NORMAL RATIO". CONTRAST USED WAS BAYER. INFLATION DEVICE WAS MERIT. THERE WAS NO DIFFICULTY TRACKING THE DEVICE THROUGH THE VESSEL OR CROSSING THE LESION WITH THE BALLOON. WHEN IT WAS NOTICED THAT THE BALLOON HAD RUPTURED, THE PHYSICIAN REMOVED THE BALLOON FROM THE PATIENT AND A RYUJIN PLUS BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ONE NON STERILE SAKURA FIRE STAR, 2.50 X 20 MM WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. BLOOD WAS INSIDE THE BALLOON. A KINK WAS FOUND AT 68.5 CM FROM PROXIMAL END, THIS CONDITION COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR ANALYSIS. PRESSURIZED WATER WAS APPLIED TO THE CATHETER USING AN INDEFLATOR, AND A LEAK IN THE SHAFT WAS OBSERVED AT 20.5CM FROM DISTAL END. ALSO PRESSURIZED WATER WAS APPLIED AS AN ATTEMPT TO INFLATE THE BALLOON AND A LEAKAGE WAS FOUND AT PROXIMAL SECTION OF THE BALLOON. SEM RESULTS SHOWED THAT THE SHAFT LEAKAGE COULD HAVE BEEN CAUSED BY EXTERNAL SURFACE DAMAGE. THE OUTER BODY AND THE INNER BODY BOTH PRESENT EVIDENCE OF HEAVY SURFACE DAMAGE; WALL CHARACTERISTICS SUGGEST AN INTERACTION BETWEEN WHAT APPEARS TO BE A CUTTING OR SHARP TOOL AND THE SHAFT. THE EXACT CAUSE AND TIME OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASIONS NEAR THE LEAK-HOLE. THE BALLOON INNER SURFACE EXHIBITED EVIDENCE OF MINOR SCRATCHES. THE EXACT CAUSE OF THE BALLOON LEAK COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BAND EXHIBITED NO ANOMALIES. 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 BURST REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE REPORTED BALLOON RUPTURE AND SHAFT LEAKAGE FOUND ON THE RETURNED DEVICE COULD NOT DEFINITIVELY BE DETERMINED; HOWEVER, BASED ON THE ANALYSIS, IT APPEARS THAT VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED. BASED ON THE DHR REVIEW AND THE PRODUCT ANALYSIS, THERE IS NO INDICATION OF ANY RELATIONSHIP TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN INFLATED THE BALLOON AT 8 ATM, IT COULD NOT BE FURTHER INFLATED, THE PHYSICIAN THEN DEFLATED THE BALLOON, HOWEVER, BLOOD WAS OBSERVED DURING DEFLATION. THEN THE PHYSICIAN WITHDREW THE BALLOON OUTSIDE PATIENT, HE FOUND THE BALLOON WAS HOLE RUPTURED. THE PRODUCT WAS RETURNED FOR EVALUATION AND DURING ANALYSIS, IT WAS NOTED THAT WHEN PRESSURIZED WATER WAS APPLIED TO THE CATHETER USING AN INDEFLATOR, A LEAK IN THE SHAFT WAS OBSERVED AT 20.5CM FROM DISTAL END. THE AGE AND GENDER OF THE PATIENT IS UNKNOWN. THE TARGET LESION LOCATION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS TYPE B. THE RATE OF STENOSIS WAS 85%. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED PRIOR TO USE. A RADIAL APPROACH WAS USED TO ACCESS THE PATIENT. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. NORMAL RATIO OF CONTRAST AND SALINE WAS USED TO INFLATE THE BALLOON. CONTRAST USED WAS BAYER. INFLATION DEVICE WAS MERIT. THERE WAS NO DIFFICULTY TRACKING THE DEVICE THROUGH THE VESSEL OR CROSSING THE LESION WITH THE BALLOON. WHEN IT WAS NOTICED THAT THE BALLOON HAD RUPTURED, THE PHYSICIAN REMOVED THE BALLOON FROM THE PATIENT AND A RYUJIN PLUS BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRE STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 15179251

    Patients

    Seq Age Sex Outcome Treatment
    1 MERIT INDEFLATOR