BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 3110769 · Received May 14, 2013

    Report

    Report Number
    9616099-2013-00293
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED BY AN AFFILIATE, A POWERFLEX PRO BALLOON RUPTURED DURING INITIAL INFLATION AT 12 TO 13 ATMOSPHERES. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY WHICH WAS A DE NOVO, BUT WAS HEAVILY CALCIFIED AND NOT TORTUOUS WITH AN UNKNOWN PERCENTAGE OF STENOSIS. IT WAS NOT INDICATED IF THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THOUGHT THE VESSEL. THE BALLOON RUPTURE WAS CONFIRMED DUE TO THE LEAKAGE OF CONTRAST MEDIUM NOTED UNDER THE X-RAY. THE PHYSICIAN REMOVED THE POWERFLEX PRO INTACT WITHOUT DIFFICULTY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, BUT IT WAS FINISHED SUCCESSFULLY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY AND MAINTAINED NEGATIVE PRESSURE. THE BRAND OF INDEFLATOR , CONTRAST AND CONTRAST TO SALINE RATIO USED ARE UNKNOWN. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THERE WAS NO PATIENT INJURY REPORTED. ONE NON STERILE POWER FLEX PRO 4.0MM X 10.0CM 135.0CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEAR HAVE BEEN INFLATED. AN AXIAL BALLOON BURST WAS OBSERVED. THERE WERE INFLATION MEDIUM RESIDUES OBSERVED IN THE BALLOON. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. A LEAK COULD NOT BE PERFORMED DUE TO BALLOON CONDITIONS. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF BALLOON BURST. RESULTS SHOWED THAT NEITHER THE EXTERNAL NOR THE INTERNAL BALLOON SURFACES EXHIBITED EVIDENCE OF SCRATCHES, ABRASIONS OR ANY OTHER KIND OF DAMAGE. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE MARKER BANDS EXHIBITED NO ANOMALIES. THERE IS NO EVIDENCE OF DAMAGE INDUCED BY A TOOL. 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 - BURST-AT/BELOW RBP¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE; HOWEVER, THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE VESSEL CHARACTERISTICS (HEAVY CALCIFICATION) THAT MAY HAVE CONTRIBUTED TO THE BALLOON BURST. NEITHER THE DHR REVIEW, PRODUCT ANALYSIS NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, A POWERFLEX PRO BALLOON RUPTURED DURING INITIAL INFLATION AT 12-13 ATMOSPHERES (ATM) WITH AN UNKNOWN DEVICE. THEREFORE, THE PHYSICIAN REMOVED THE POWERFLEX PRO WITH NO DIFFICULTY AND INTACT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED, BUT IT WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NO DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY, MAINTAIN NEGATIVE PRESSURE. IT IS UNKNOWN THE CONTRAST TO SALINE RATIO USED. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE POWERFLEX PRO (4.0/100MM 135CM) WAS DELIVERED TO THE TARGET LESION AND BALLOON WAS INFLATED AT THE LESION. IT WAS NOT INDICATED IF THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THOUGHT THE VESSEL. THE BALLOON RUPTURE WAS CONFIRMED DUE TO THE LEAKAGE OF THE UNKNOWN CONTRAST MEDIUM UNDER THE X-RAY. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE BALLOON CATHETER DID NOT KIN WHILE BEING USED. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS A DE NOVO, BUT WAS HEAVILY CALCIFIED AND NOT TORTUOUS. THE PERCENTAGE OF THE STENOSIS WAS UNKNOWN. THE PHYSICIAN COMMENTED THAT THERE WAS HEAVILY CALCIFICATION AT THE LESION. THE PRODUCT WILL BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211971 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS LIT CORDIS DE MEXICO NA 15766958

    Patients

    Seq Age Sex Outcome Treatment
    1