BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX EXTREME PTA DILATATION CATHETER

    MDR report key: 3893870 · Received June 25, 2014

    Report

    Report Number
    9616099-2014-00410
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE GENDER OF THE PATIENT IS UNKNOWN. THE LOT NUMBER WAS PROVIDED AS 4156040S, ON THE COMPLAINT FORM. HOWEVER, THIS IS A CATALOG NUMBER AND IS NOT A VALID LOT NUMBER. ADDITIONAL INFORMATION/CLARIFICATION IS PENDING.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS RETURNED FOR ANALYSIS. LOT NUMBER INFORMATION WAS RECEIVED. LOT 15426516. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING USE OF A 6X4 80CM POWERFLEX EXTREME PTA BALLOON IT WAS REPORTED THAT THE BALLOON WAS ¿TORN¿ UNDER RATED BURST PRESSURE (RBP) DUE TO HEAVY CALCIFIED LESION. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE CATHETER POWER FLEX EXTREME 6.0MM X 4.0CM 80.0CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEARED TO HAVE BEEN PARTIALLY INFLATED. NO RESIDUES WERE OBSERVED IN THE RETURNED DEVICE. THE LEAK TEST REQUIRED COULD NOT BE PERFORMED SINCE LEAKAGE WAS OBSERVED AT 2.0CM FROM DISTAL TIP END. THE DEVICE WAS SENT FOR SEM ANALYSIS TO IDENTIFY THE CAUSE OF BALLOON LEAKAGE. RESULTS SHOWED THAT THE BALLOON EXTERNAL AND INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE HOWEVER A BALLOON PINHOLE WAS NOTED. THE CAUSE OF THE PINHOLE COULD NOT BE DETERMINED ON ANALYSIS. THIS BALLOON LEAKAGE FAILURE EXHIBITED NO SURFACE ANOMALIES THAT COULD HAVE BEEN RELATED TO THE FAILURE. THE DISTAL MARKER BAND EXHIBITED NO ANOMALIES. REVIEW OF LOT 15426516 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED COMPLAINT ¿BURST-AT/BELOW RBP¿ WAS CONFIRMED SINCE LEAKAGE WAS OBSERVED IN THE BALLOON DUE TO A BALLOON PINHOLE. THE EXACT CAUSE OF BALLOON PINHOLE COULD NOT BE CONCLUSIVELY DETERMINED DURING ANALYSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (HEAVILY CALCIFIED LESION). NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE REPORTED ¿BURST¿ IS RELATED TO THE DESIGN OR MANUFACTURING OF THE DEVICE, THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT A 6X4 80CM POWERFLEX EXTREME PTA BALLOON WAS TORN UNDER RATED BURST PRESSURE (RBP) DUE TO HEAVY CALCIFIED LESION. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371963 POWERFLEX EXTREME PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1