BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1203201 · Received October 10, 2008

    Report

    Report Number
    2024168-2008-00939
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON DILATATION CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE BALLOON, AND ON THE INFLATION LUMEN, IN AND ON THE HUB. THERE WAS CONTRAST VISIBLE ON THE BALLOON AND ON THE INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A LONGITUDINAL TEAR ON THE BALLOON, 5 MM PROXIMAL TO THE TIP FOR A LENGTH OF 1.4 CM. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON DILATATION CATHETER. THE CATHETER WAS SOAKED IN A WARM WATER BATH OVERNIGHT TO CLEAR THE BLOOD IN THE BALLOON TO CHECK FOR SCRATCHES ON THE BALLOON. THERE WERE SCRATCHES AT THE MIDDLE PORTION OF THE BALLOON FOR A LENGTH OF 7 MM. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE RETURNED DEVICE ANALYSIS REPORTEDLY, THERE WERE NO ADVERSE PATIENT EFFECTS OBSERVED AS A RESULT OF THE REPORTED DISCREPANCY. FACTORS THAT CAN AFFECT THE INABILITY TO INFLATE THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL/LESION MORPHOLOGY AND PATIENT DISEASE STATE, CONTRAST CONCENTRATION, LEAKS OR BALLOON TEARS, MANUFACTURING, INFLATION LUMEN OBSTRUCTION, INTERACTION WITH ACCESSORIES (INDEFLATOR, RHV, OR GUIDING CATHETER), PLACEMENT OF THE BALLOON WITHIN LESION, OR INFLATION TECHNIQUE. THE CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE INFLATION LUMEN AND THE BALLOON, WHICH WAS LOOSELY FOLDED. THIS IS CONSISTENT WITH A LEAK OR BALLOON TEAR AND INDICATES THAT THE BALLOON MAY HAVE BEEN PRESSURIZED AT SOME POINT DURING THE PROCEDURE. IN THIS CASE, THE ANALYSIS REVEALED A LONGITUDINAL TEAR ON THE PROXIMAL END OF THE BALLOON. ADDITIONALLY, THERE WERE SCRATCHES EVIDENT ON THE OUTER SURFACE OF THE BALLOON ADJACENT TO THE TEAR. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES OR THE PATIENT ANATOMY, SUCH THAT THE BALLOON TORE UPON INFLATION. THEREFORE, BASED ON THE INCIDENT INFORMATION AND RETURNED DEVICE ANALYSIS, THE BALLOON DAMAGE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE DEVICE. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY ISSUE IN THIS CASE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. 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 BALLOON WAS FOUND UNABLE TO BE INFLATED NORMALLY DURING PCI. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. BASED ON THE RETURN GOODS LAB ANALYSIS OF THE DEVICE, WHICH REVEALED A BALLOON RUPTURE, THIS EVENT IS BEING UPGRADED TO A MALFUNCTION MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7030932

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR STENT: FIREBIRD 4.0 X 23| GUIDE CATH: 6 F EBU3.75 GC| GUIDE WIRE: PILOT 50