BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1038902 · Received May 1, 2008

    Report

    Report Number
    2024168-2008-00363
    Event Type
    Malfunction
    Date Received
    May 1, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VOYAGER BALLOON CATHETER (1011392-15/LOT# 8011031), THE EVENT DESCRIPTION CONCOMITANT MEDICAL PRODUCTS, IS THE SECOND VOYAGER USED DURING THE PROCEDURE, IS BEING FILED UNDER THIS MFR#. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE VOYAGER BALLOON CATHETERS WERE RETURNED AND WITH BLOOD VISIBLE IN THE HUB AND INFLATION LUMEN OF THE FIRST VOYAGER AND ON THE HUB OF THE SECOND VOYAGER. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN OF THE FIRST VOYAGER AND CRYSTALLIZED CONTRAST VISIBLE IN THE INFLATION LUMEN OF THE SECOND VOYAGER. THE BALLOON OF THE FIRST VOYAGER WAS LOOSELY FOLDED. THE FIRST VOYAGER HAD A 9 MM LONGITUDINAL BALLOON RUPTURE, 4 MM DISTAL TO THE PROXIMAL MARKER AND 1.1 CM LONGITUDINAL RUPTURE WAS OBSERVED BETWEEN THE BALLOON MARKERS IN THE SECOND VOYAGER BALLOON CATHETER. THERE WERE LONGITUDINAL SCRATCHES FOUND DISTAL TO BOTH OF THE RUPTURES. THERE WAS A KINK IN THE HYPOTUBE 55.5 CM DISTAL TO THE STRAIN RELIEF TUBING OF THE FIRST VOYAGER. THERE WAS NO OTHER DAMAGES NOTED TO THE VOYAGER BALLOON CATHETERS. PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED CASE DESCRIPTION AND ANALYSIS OF THE RETURNED DEVICES; DAMAGE WAS NOTED. ANALYSIS OF BOTH RETURNED BALLOON CATHETERS WERE ABLE TO CONFIRM THE COMPLAINT AS A 9 MM LONGITUDINAL RUPTURE DISTAL TO THE PROXIMAL MARKER WAS OBSERVED IN THE FIRST VOYAGER AND 1.1 CM LONGITUDINAL RUPTURE WAS OBSERVED BETWEEN THE BALLOON MARKERS IN THE SECOND VOYAGER BALLOON CATHETER, IN ADDITION, ON BOTH BALLOON CATHETERS SCRATCHES WERE OBSERVED DISTAL TO THE BALLOON RUPTURES, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. FACTORS THAT MAY CONTRIBUTE TO BALLOON DAMAGE MAY INCLUDE, BUT NOT LIMITED TO, MFR, MATERIALS, PT ANATOMY, PT DISEASE STATE, ASSOCIATIVE DEVICE INTERACTION, LESION TORTUOSITY, OVER INFLATION, OR INSUFFICIENT PREPARATION PRIOR TO USE. THERE WAS NO PT ANATOMY DESCRIBED IN THE CASE DETAILS, WHICH MAY HAVE AIDED THE INVESTIGATION. THE POSITION OF THE SCRATCH DAMAGE TO THE BALLOON RUPTURES SUGGESTS IT IS POSSIBLE THAT DURING POSITIONING OF THE BALLOON CATHETERS, A SHARP OBJECT MAY HAVE MADE CONTACT WITH THE BALLOONS. THE SCRATCHES ON THE SURFACE ON OF THE BALLOONS APPEAR TO HAVE WEAKENED THE BALLOON MATERIAL, THEREFORE LEADING TO BALLOON RUPTURES UPON INFLATION. A DEFINITE ROOT CAUSE OF THE SCRATCHES COULD NOT BE DETERMINED BUT APPEAR TO BE RELATED TO CIRCUMSTANCES DURING THE PROCEDURE. BOTH VOYAGER PARTS WERE INFLATED ABOVE THE RBP, 14 ATMS, DURING THE PROCEDURE, ONE OF THE RUPTURES OCCURRED DURING AN ATTEMPT TO INFLATE TO 18 ATMS. THE INSTRUCTIONS FOR USE (IFU) WARNS AGAINST OVER-INFLATION OF THE BALLOON CATHETER DEVICE. IFU STATES "BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURES (RBP). THE RBP IS BASED ON RESULTS OF INVITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RBP." A KINK WAS OBSERVED 55.5 CM DISTAL TO THE STRAIN RELIEF TUBING ON THE FIRST VOYAGER PART. SINCE, THE DAMAGE WAS NOT NOTED IN THE CASE DETAILS, IT LIKELY OCCURRED AFTER THE PROCEDURE DUE TO HANDLING OR TRANSPORT BACK TO ABBOTT. THE KINK DAMAGE DID NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE MFG LOT HISTORY RECORDS WAS REVIEWED. THERE ARE NO NONCONFORMANCE'S ASSOCIATED WITH THIS PRODUCT PART/LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RAPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PT DURING AN ACUTE MYOCARDIAL INFARCTION (AMI) CASE. THE FIRST VOYAGER BALLOON CATHETER WAS BEING USED TO DILATE A CALCIFIED LAD AND THE FIRST INFLATION WAS TO 10 ATMS. THEN, A SECOND INFLATION WAS DONE AT 8 ATMS. HOWEVER, DURING A THIRD INFLATION TO 18 ATMS (ABOVE RATED BURST PRESSURE), THE BALLOON RUPTURED. THEN, ANOTHER VOYAGER OF THE SAME SIZE WAS USED AND TWO INFLATIONS WERE MADE WITH THIS BALLOON. THE FIRST INFLATION TO 15 ATMS (ABOVE RATED BURST PRESSURE), AND THE SECOND TO 12 ATMS, WHEN THE BALLOON RUPTURED. A POWERSAIL BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THERE WERE NO PT EFFECTS. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8011031

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR DIL CATH: