BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1031697 · Received April 18, 2008

    Report

    Report Number
    2024168-2008-00322
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR WAS FILLED WITH WATER AND AN ATTEMPT WAS MADE TO PRESSURIZE THE BALLOON WHEN WATER LEAKED OUT OF A LONGITUDINAL RUPTURE 5 MM DISTAL TO THE PROXIMAL MARKER. THE RUPTURE WAS .5 MM LONG. THERE WERE NO SCRATCHES NOTED. THE DEVICE WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED CASE DESCRIPTION AND ANALYSIS OF THE RETURNED DEVICE; DAMAGE WAS NOTED. THE ANALYSIS WAS ABLE TO CONFIRM THE REPORTED DIFFICULTIES AS A .5 MM LONG LONGITUDINAL RUPTURE WAS OBSERVED .5 MM DISTAL TO THE PROXIMAL BALLOON MARKER. FACTORS THAT MAY CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT NOT LIMITED TO, MANUFACTURING, MATERIALS, OVER INFLATION OF THE BALLOON, PATIENT ANATOMY OR DISEASE STATE, AND ASSOCIATIVE DEVICE INTERACTION. THE PATIENT ANATOMY WAS 75% STENOSED WITH NO OBSERVED CALCIFICATION. SEM ANALYSIS OF THE BALLOON RUPTURE SHOWS MECHANICAL DAMAGE TO THE OUTER SURFACE OF THE BALLOON. THE MECHANICAL DAMAGE TO THE BALLOON APPEARS TO HAVE WEAKENED THE MATERIAL, AND UPON INFLATION, THE BALLOON RUPTURED. A REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT NO UNITS WERE REJECTED DURING THE INSPECTION FOR BALLOON DAMAGE OR LEAKS AT THE BALLOON.. THERE WERE NO DIFFICULTIES OBSERVED DURING THE PREPARATION PROCEDURE. A DEFINITE ROOT CAUSE OF THE OUTER SURFACE DAMAGE COULD NOT BE DETERMINED. THE DAMAGE MAY POSSIBLY BE RELATED TO CIRCUMSTANCES DURING THE PROCEDURE. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS PRODUCT PART / LOT NUMBER. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE TARGET LESION WAS 75% STENOSED AND NO CALCIFICATION WAS OBSERVED. DURING THE FIRST INFLATION WITH THE VOYAGER, THE BALLOON RUPTURED AT 10-12 ATM. ANOTHER COMPANY'S 2.5 X 15 BALLOON WAS USED NEXT AND THE PROCEDURE WAS COMPLETED WITH IMPLANTING ANOTHER COMPANY'S STENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 6120731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: TAXUS| DIL CATH: RYUJIN 2.5X15