BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 2243330 · Received September 12, 2011

    Report

    Report Number
    9616099-2011-00721
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    February 14, 2011
    Report Date
    August 30, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P880003/S90
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY FROM THE VESSEL, FROM SHEATH, FROM THE RHV (ROTATING HEMOSTATIC VALVE), FROM THE GUIDEWIRE AND FROM THE GUIDE CATHETER. THERE WAS NO PATIENT INJURY OR IMPACT TO THE PATIENT. THE DEVICE WAS CHANGED FOR ANOTHER ONE TO COMPLETE THE PROCEDURE. THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RETURNED YET. 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. REVIEW OF LOT 15196793 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT A (B)(4) FIRE STAR BALLOON HAD INFLATION AND DEFLATION DIFFICULTY. THE BALLOON COULD NOT BE FULLY INFLATED AND THE PHYSICIAN ALSO HAD DIFFICULTY IN DEFLATING THE BALLOON. THE TARGET LESION WAS A 90% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS SLIGHTLY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO DIFFICULTY EXPERIENCED WITH THE DEVICE DURING REMOVAL FROM THE PACKAGE OR DURING PREP. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON INTO THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THERE WAS NO LEAKAGE NOTED FROM THE BALLOON, SHAFT, HUB, OR ANY OTHER SEGMENT. THE MAXIMUM INFLATION PRESSURE WAS 14 ATM. THE BALLOON MAINTAINED PRESSURE DURING INFLATION. THE BALLOON COULD NOT FULLY DEFLATE IN 1-2 MINUTES. THE BALLOON COULD NOT INFLATE FULLY, WHEN THE PHYSICIAN DEFLATED THE BALLOON, IT DEFLATED VERY SLOWLY BUT FINALLY IT DID RE-WRAPPED. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED EASILY FROM THE VESSEL, FROM SHEATH, FROM THE RHV (ROTATING HEMOSTATIC VALVE), FROM THE GUIDEWIRE AND FROM THE GUIDE CATHETER. THE DEVICE WAS CHANGED FOR ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR IMPACT TO THE PATIENT. ONE NON-STERILE 2.50X 20 MM (B)(4) FIRESTAR WAS RECEIVED INSIDE TWO PLASTIC BAGS. ONE KINK WAS NOTICED AT 11.5 CM FROM DISTAL END; THIS CONDITION COULD BE RELATED TO THE WAY THAT THE UNIT WAS SENT TO THE ANALYSIS. THE BALLOON WAS ALREADY INFLATED AND CONTRAST MEDIUM RESIDUES WERE OBSERVED. INFLATION/ DEFLATION FUNCTIONAL TEST WAS PERFORMED AND THE TIMES WERE FOUND WITHIN SPECIFICATION PARAMETERS. SEM RESULTS SHOWED THAT THE TRANSITION SEAL AND THE PROXIMAL SEAL PRESENTED NO EVIDENCE OF BLOCKAGE OR ANY OTHER ANOMALY THAT COULD BE RELATED TO THE REPORTED FAILURE. THE SAMPLE EXHIBITED NO EVIDENCE OF INTERNAL OR EXTERNAL SURFACE MATERIAL DAMAGE. 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 FAILURES WERE NOT CONFIRMED. THE EXACT CAUSE OF THE REPORTED FAILURES COULD NOT BE DETERMINED. IT IS LIKELY THAT PROCEDURAL FACTORS COULD CONTRIBUTE TO THE ISSUE EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT REPORTER ISSUES ARE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN. THE REPORTED COMPLAINTS WERE NOT CONFIRMED ON ANALYSIS. THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS. 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. THE BRAND OF INFLATOR AND CONTRAST USED AS WELL AS THE CONTRAST TO SALINE RATIO ARE UNKNOWN IN THIS CASE. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT BALLOON INFLATION/DEFLATION DIFFICULTY WAS EXPERIENCED: THE BALLOON COULD NOT BE FULLY INFLATED AND THE PHYSICIAN ALSO HAD DIFFICULTY IN DEFLATING THE BALLOON. THE TARGET LESION WAS A 90% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS SLIGHTLY CALCIFIED. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO DIFFICULTY EXPERIENCED WITH THE DEVICE DURING REMOVAL FROM THE PACKAGE OR DURING PREP. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON INTO THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THERE WAS NO LEAKAGE NOTED FROM THE BALLOON, SHAFT, HUB, OR ANY OTHER SEGMENT. THE MAXIMUM INFLATION PRESSURE WAS 14 ATM. THE BALLOON MAINTAINED PRESSURE DURING INFLATION. THE BALLOON COULD NOT FULLY DEFLATE IN 1-2 MINUTES. THE BALLOON COULD NOT INFLATE FULLY, WHEN THE PHYSICIAN DEFLATED THE BALLOON, IT DEFLATED VERY SLOW AND FINALLY IT DID RE-WRAPPED. THE CATHETER COULD BE REMOVED EASILY.

    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 15196793

    Patients

    Seq Age Sex Outcome Treatment
    1 MERIT INDEFLATOR