BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERSAIL CORONARY DILATATION CATHETER

    MDR report key: 1021526 · Received March 26, 2008

    Report

    Report Number
    2024168-2008-00218
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 25, 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

    RESULT AND CONCLUSION SUMMATION-QUALITY ENGINEERING REVIEWED THE INCIDENT INFORMATION. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDED, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, LESION CALCIFICATION LESION TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. IT IS POSSIBLE THAT A STENT STRUT PROTRUDED INTO THE BALLOON DUE TO THE CALCIFICATION, ANATOMICAL MORPHOLOGY, OR PT DISEASE STATE RESULTING IN A RUPTURE, OT THAT CALCIFICATION PIERCED THE BALLOON. THE DISCREPANCY APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE, HOWEVER, WITHOUT THE DEVICE TO EXAMINE, NO DETERMINATION CAN BE MADE AS THE ROOT CAUSE OF THE REPORTED DISCREPANCY.

    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 THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WHICH HAD NO TORTUOSITY, MODERATE CALCIFICATION, AND A 75% STENOSIS. THE VESSEL DIAMETER WAS 3.0 MM. AFTER DEPLOYING THE STENT DIRECTLY, THE POWERSAIL WAS DELIVERED TO PERFORM POST-DILATION; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 14 ATM. THE PHYSICIAN COMMENTED THAT THE RUPTURE MAY BE DUE TO THE BALLOON COMING INTO CONTACT WITH STENT STRUT OR SHARP CALCIFICATION. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERSAIL CORONARY DILATATION CATHETER 74LOX LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7090151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OTHER: IVUS| GUIDE CATHETER: RUNWAY 6F JL4| DILATATION CATHETER: HIRYU 3.0 X 10| GUIDE WIRE: RUNTHROUGH| STENT: VISION 3.0 X 23