BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1621150 · Received March 1, 2010

    Report

    Report Number
    2024168-2010-00378
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 19, 2010
    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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE BALLOON RUPTURE. THE 2.0 X 15MM VOYAGER (PART 1011392-15, LOT 9070761), WAS FILED UNDER MFR # 2024168-2010-00317. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH CONTRAST IN THE BALLOON, IN THE INFLATION LUMEN AND ON THE SHAFT. THERE WAS NO BLOOD VISIBLE. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A LONGITUDINAL RUPTURE IN THE DISTAL TAPER OF THE BALLOON FOR A LENGTH OF 1.1 CM PROXIMALLY. THERE WERE NO VISIBLE SCRATCHES. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE VOYAGER WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER INVESTIGATION. PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED THE INCIDENT INFO AND THE ANALYSIS OF THE RETURNED PRODUCT. ANALYSIS OF THE RETURNED VOYAGER IS CONSISTENT WITH THE REPORTED INFO THAT THE PRODUCT WAS PREPARED FOR USE AND ATTEMPTS WERE MADE TO INFLATE THE BALLOON. THE ANALYSIS REVEALED THAT THERE WAS A LONGITUDINAL RUPTURE IN THE DISTAL TAPER OF THE BALLOON THAT EXTENDED PROXIMALLY FOR A LENGTH OF 1.1 CM. THE BALLOON WAS SENT TO THE SEM LAB FOR FURTHER ANALYSIS, WHICH DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO DAMAGE INITIATING FROM THE INSIDE OF THE BALLOON AS THERE WERE PARTIAL LONGITUDINAL TEARS OBSERVED ALONG THE INNER SURFACE. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS, DAMAGE TO THE INNER SURFACE OF THE BALLOON IS MOST CONSISTENT WITH EXPOSURE CONDITIONS DURING THE PROCEDURE, HIGH STRESS BEING APPLIED TO THE BALLOON MATERIALS AND/OR MULTIPLE INFLATIONS DURING THE PROCEDURE. SINCE THIS DAMAGE WAS NOT REPORTED DURING PRODUCT INSPECTION, AND THERE WERE NO LEAKS NOTED AS THE CATHETER WAS PREPARED FOR USE, THIS SUGGESTS THAT THE RUPTURE OCCURRED DURING OR AFTER THE PROCEDURE. FURTHERMORE, THE LESION WAS REPORTED AS MODERATELY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED RUPTURE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MFG CRITERIA. IN THIS INSTANCE, BASED ON THE INFO RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, THE REPORTED DIFFICULTY INFLATING THE CATHETER APPEARS TO BE RELATED TO THE LONGITUDINAL RUPTURE IN THE BALLOON; HOWEVER, A DEFINITE CAUSE FOR THE BALLOON RUPTURE CANNOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MFG PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE BALLOON COULD NOT BE DILATED IN THE LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY, WHICH HAD MODERATE CALCIFICATION. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE. THIS IS BEING FILED BASED ON THE RETURNED PRODUCT ANALYSIS WHICH REVEALED A BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9081261

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILATATION CATHETER: 2.0X15MM VOYAGER| (PART 1011392-15, LOT 9070761)