BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRE STAR RX PTCA BALLOON CATHETER

    MDR report key: 3840512 · Received May 30, 2014

    Report

    Report Number
    9616099-2014-00356
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 8, 2014
    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 DEVICE HAS BEEN RETURNED, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. A DEVICE HISTORY RECORD (DHR) REVIEW AND ADDITIONAL INFORMATION ARE PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THE GENDER OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED BY THE AFFILIATE, THE BALLOON OF A 2X20MM FIRE STAR PTCA CATHETER WITHDREW WITH DIFFICULTY FROM THE LESION AFTER PRE-DILATION. THE SURGEON THOUGHT THE BALLOON DID NOT RE-WRAP PROPERLY. THE SURGEON TRIED MANY WAYS TO WITHDRAW IT UNTIL IT WAS REMOVED. NO ADVERSE EVENT ON THE PATIENT. THE INTENDED PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION OF A TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING. THE LESION AS MODERATELY CALCIFIED WITH 90% STENOSIS AND THE VESSEL WAS TORTUOUS. FOR THE PROCEDURE, A 2X20MM FIRE STAR PTCA CATHETER WAS OPENED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON OR STYLET. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY. THERE WAS NO RESISTANCE/FRICTION OR DIFFICULTY NOTED WHILE INSERTING THE BALLOON INTO THE PATIENT AND TO THE LESION. THE CATHETER WAS IN AN ACUTE BEND DURING THE PROCEDURE. AT THE LESION, THE BALLOON INFLATED NORMALLY WITH A MAXIMUM INFLATION PRESSURE OF 14 ATMOSPHERES AND MAINTAINED PRESSURE. THE BALLOON DEFLATED NORMALLY, HOWEVER, THE SURGEON THOUGHT THE BALLOON DID NOT RE-WRAP PROPERLY. THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE LESION. THE SURGEON TRIED MANY TIMES TO REMOVE IT. THE DEVICE DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). THERE WAS NO PATIENT INJURY. THE PATIENT IS CURRENTLY FINE. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON STERILE SAKURA FIRE STAR, 2.00 X 20 WAS RECEIVED COILED INSIDE A PLASTIC BAG. BALLOON WAS ALREADY INFLATED. RESIDUES OF INFLATION MEDIUM WERE OBSERVED IN THE INFLATION LUMEN. NO OTHER DAMAGES WERE FOUND. OUTER DIAMETER WAS MEASURE AND FOUND WITHIN SPECIFICATION. THE DEVICE WAS INSERTED / WITHDRAWN THROUGH GUIDING CATHETER 5F (LABORATORY SAMPLE) AND NOT RESISTANCE WAS FELT. THE BALLOON WAS INFLATED/DEFLATED WITHOUT ANY PROBLEM. 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 ¿BALLOON - WITHDRAWAL DIFFICULTY¿ AND ¿BALLOON - RE-WRAPPING DIFFICULTY¿ WERE NOT CONFIRMED AS THE DEVICE PREFORMED AS INTENDED DURING FUNCTIONAL ANALYSIS. THE CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (TORTUOSITY) MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE WITHDRAWAL DIFFICULTY OR REPORTED RE-WRAPPING DIFFICULTY OF THE BALLOON IS MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. PRODUCT ANALYSIS WAS PROVIDED: ONE NON STERILE SAKURA FIRE STAR, 2.00 X 20 WAS RECEIVED COILED INSIDE A PLASTIC BAG. BALLOON WAS ALREADY INFLATED. RESIDUES OF INFLATION MEDIUM WERE OBSERVED IN THE INFLATION LUMEN. NO OTHER DAMAGES WERE FOUND. OUTER DIAMETER WAS MEASURE AND FOUND WITHIN SPECIFICATION. THE DEVICE WAS INSERTED / WITHDRAWN THROUGH GUIDING CATHETER 5F (LABORATORY SAMPLE) AND NOT RESISTANCE WAS FELT. THE BALLOON WAS INFLATED/DEFLATED WITHOUT ANY PROBLEM. 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 FAILURES REPORTED ¿BALLOON - WITHDRAWAL DIFFICULTY¿ AND ¿BALLOON - RE-WRAPPING DIFFICULTY¿ BY THE CUSTOMER WERE NOT CONFIRMED; SINCE NO ANOMALIES WERE FOUND DURING DIMENSIONAL AND FUNCTIONAL ANALYSES. THE CAUSE OF THE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING PROCESS. THEREFORE, NO ACTIONS WERE TAKEN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE AFFILIATE, THE BALLOON WITHDREW WITH DIFFICULTY FROM THE LESION AFTER PRE-DILATION. THE SURGEON THOUGHT THE BALLOON DID NOT RE-WRAP PROPERLY. THE SURGEON TRIED MANY WAYS TO WITHDRAW IT UNTIL IT WAS REMOVED. NO ADVERSE EVENT ON THE PATIENT. THE INTENDED PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION OF A TARGET LESION LOCATED IN THE LEFT ANTERIOR DESCENDING. THE LESION AS MODERATELY CALCIFIED WITH 90% STENOSIS AND THE VESSEL WAS TORTUOUS. FOR THE PROCEDURE, A 2X20MM FIRE STAR PTCA CATHETER WAS OPENED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, OR REMOVING THE PROTECTIVE BALLOON COVER AND STYLET. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY. THERE WAS NO RESISTANCE/FRICTION OR DIFFICULTY NOTED WHILE INSERTING THE BALLOON INTO THE PATIENT AND TO THE LESION. THE CATHETER WAS IN AN ACUTE BEND DURING THE PROCEDURE. AT THE LESION, THE BALLOON INFLATED NORMALLY WITH A MAXIMUM INFLATION PRESSURE OF 14 ATMOSPHERES AND MAINTAINED PRESSURE. THE BALLOON DEFLATED NORMALLY, HOWEVER, THE SURGEON THOUGH THE BALLOON DID NOT RE-WRAP PROPERLY. THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE LESION. THE SURGEON TRIED MANY TIMES TO REMOVE IT. THE DEVICE DID NOT KINK WHILE BEING USED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). THERE WAS NO PATIENT INJURY. THE PATIENT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318768 FIRE STAR RX PTCA BALLOON CATHETER PTCA BALLOON CATHETERS (LOX) LOX CORDIS DE MEXICO NA 15870139

    Patients

    Seq Age Sex Outcome Treatment
    1