BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .018 PERIPHERAL DILATATION CATHETER

    MDR report key: 1035296 · Received April 24, 2008

    Report

    Report Number
    3004742046-2008-00089
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 30, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND A LONGITUDINAL RUPTURE AND A RADIAL RUPTURE IN THE BALLOON DISTAL TO THE PROXIMAL SHOULDER. INFLATION AND DEFLATION COULD NOT BE PERFORMED BECAUSE OF THE BALLOON RUPTURE. NO OTHER DAMAGE WAS OBSERVED ON THE CATHETER, AND NO MANUFACTURING ISSUES WERE DETECTED. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS CONFIRMED MECHANICAL DAMAGE TO THE OUTER SURFACE OF THE BALLOON. THE CUSTOMER REPORTED USE OF THE DEVICE IN A HEAVILY CALCIFIED STENOSIS WHICH COULD HAVE CONTRIBUTED TO THE EVENT; HOWEVER, THIS CANNOT BE CONFIRMED. NO ROOT CAUSE COULD BE DETERMINED FOR THE BALLOON RUPTURE BASED ON THE INVESTIGATION FINDINGS. A REVIEW OF THE LOT HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. ALL BALLOON CATHETERS ARE 100%VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. IN ADDITION, RELIABILITY ENGINEERING (RE) PERFORMS RATED BURST PRESSURE (RBP) TESTING FROM EACH MANUFACTURING LOT TO VERIFY THAT THE RBP PRODUCT SPECIFICATION IS MET. A REVIEW OF THE RE DATA FOR THIS LOT SHOWED THAT THE RBP DATA EXCEEDED RBP PRODUCT SPECIFICATION. THE DEVICE #2 AGILTRAC LOT# 7101551, AND DEVICE #3 AGILTRAC LOT# 6060951 INDICATED ARE BEING FILED SEPARATELY UNDER MFR REPORT NUMBERS.

    Description of Event or Problem · 1

    DEVICE #1 MALFUNCTION: BALLOON RUPTURE DURING INFLATION. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN A HEAVILY CALCIFIED AND STENOSED PERIPHERAL VESSEL LESION, THE BALLOON RUPTURED WHILE BEING INFLATED BETWEEN 6 ATM AND 8 ATM. REPORTEDLY, A TOTAL OF THREE AGILTRAC BALLOONS RUPTURED BELOW RATED BURST PRESSURE WHILE BEING INFLATED. THE DEVICES WERE REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .018 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8011551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DEVICE #3 AGILTRAC LOT# 6060951| DEVICE #2 AGILTRAC LOT# 7101551