BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1613574 · Received February 12, 2010

    Report

    Report Number
    2024168-2010-00244
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 15, 2010
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 2.0 X 20 MM VOYAGER, (PART 1011751-20, LOT 9042561), HAS BEEN FILED UNDER MFR # 2024168-2010-00242. EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD ON THE SHAFT, HYPOTUBE, BALLOON AND IN THE GUIDE WIRE LUMEN, INFLATION LUMEN AND BALLOON. THERE WAS CRYSTALLIZED CONTRAST IN THE INFLATION LUMEN AND CONTRAST IN THE BALLOON AND ON THE SHAFT AND HYPOTUBE. THE BALLOON WAS RETURNED LOOSELY FOLDED. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO ATTEMPT TO PRESSURIZE THE BALLOON, BUT THE BALLOON COULD NOT BE PRESSURIZED DUE TO THE THICK BLOOD AND CONTRAST IN THE INFLATION LUMEN. THE BALLOON CATHETER WILL BE LEFT OVERNIGHT TO ATTEMPT TO DILUTE SOME OF THE BLOOD AND CONTRAST SO THE BALLOON COULD BE INFLATED. AFTER BEING LEFT PRESSURIZED OVERNIGHT, THE BALLOON CATHETER WAS INFLATED TO REVEAL A PINHOLE IN THE MIDDLE OF THE BALLOON 8MM DISTAL TO THE PROXIMAL BALLOON MARKER. THERE WAS A SCRATCH IN THE BALLOON FOR A LENGTH OF 0.5 MM PROXIMAL TO THE PINHOLE. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED PRODUCT. ANALYSIS OF THE RETURNED PRODUCT IS CONSISTENT WITH HANDLING OF THE PRODUCT AND THE REPORTED INFO THAT THE PRODUCT WAS INTRODUCED IN THE BODY, INFLATED AND A RUPTURE OCCURRED. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MFG, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. REPORTEDLY, THE TARGET LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. IN THIS CASE, IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED DURING INTERACTION WITH OTHER DEVICES, AND/OR LESION CALCIFICATION, SUCH THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 16ATM, AS NO DAMAGE WAS NOTED DURING PREPARATION FOR USE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. IN THIS CASE, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE, AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE EXPERIENCE 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 RATED BALLOON PRESSURE AND BALLOON INTEGRITY. 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 PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT DURING A DILATATION OF A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, THE VOYAGER NC DILATATION CATHETER BALLOON RUPTURED AT 18 ATM. A SECOND VOYAGER NC DILATATION CATHETER BALLOON RUPTURED AT 12 ATM. THERE WAS NO REPORTED ADVERSE PT EFFECT. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9091561

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (PART 1011751-20, LOT 9042561)| DILATATION CATHETER: 2.0 X 20MM VOYAGER