BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1212724 · Received October 21, 2008

    Report

    Report Number
    2024168-2008-00985
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED OUT OF A LONGITUDINAL RUPTURE OVER THE DISTAL BALLOON MARKER FOR A LENGTH OF 6 MM. THERE WERE TWO LONGITUDINAL SCRATCHES PROXIMAL TO THE RUPTURE IN THE BALLOON. PROD PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED DEVICE REPORTEDLY, THERE WERE NO ADVERSE PT EFFECTS OBSERVED AS A RESULT OF THE BALLOON RUPTURE. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MFG MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IN THIS INSTANCE, THE LESION WAS MODERATELY TORTUOUS AND CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. THE BALLOON CATHETER WAS RETURNED WITH CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON, SUGGESTING THAT THE DEVICE HAD BEEN PREPPED FOR USE AND IS CONSISTENT WITH THE BALLOON BEING PRESSURIZED AT SOME POINT. FUNCTIONAL ANALYSIS WAS ABLE TO CONFIRM A LONGITUDINAL BALLOON RUPTURE OVER THE DISTAL BALLOON MARKER FOR A LENGTH OF 6 MM. IN ADDITION, THERE WERE LONGITUDINAL SCRATCHES EVIDENT ON THE OUTER SURFACE OF THE BALLOON ADJACENT TO THE RUPTURE SITE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION. THEREFORE, BASED ON THE INCIDENT INFO AND THE RETURNED DEVICE ANALYSIS, THE BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE RESULTING FROM MECHANICAL DAMAGE TO THE BALLOON. THERE, DOES NOT APPEAR TO BE ANY INDICATIONS OF A PROD QUALITY PROBLEM IN THIS CASE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MFG CRITERIA. THIS MDR IS CONSIDERED CLOSED BY THE PROD PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS CONSIDERED LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE 2.0 X 15 MM RX VOYAGER BALLOON CATHETER CROSSED THE LESION, HOWEVER, THE BALLOON RUPTURED DURING INFLATION AT AN UNK PRESSURE. 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 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8041441

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: SUPRECORE STENT| DIL CATH: VOYAGER