BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERSAIL CORONARY DILATATION CATHETER

    MDR report key: 1060744 · Received June 11, 2008

    Report

    Report Number
    2024168-2008-00473
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE INFLATION LUMEN. THERE WAS CONTRAST VISIBLE IN THE BALLOON. THE BALLOON HAD LOOSE FOLDS. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE INFLATION DEVICE USED IN THE PROCEDURE WAS NOT RETURNED. A NEW INDEFLATOR WAS USED TO PULL NEGATIVE, THE 2/3 BALLOON OUTER DIAMETER WAS MEASURED WITH A PROFILE BLOCK AND MET MANUFACTURING CRITERIA. A SNAP GAUGE WAS USED TO MEASURE THE CROSSING PROFILE AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED FROM A PINHOLE IN THE BALLOON, AT THE DISTAL EDGE OF THE DISTAL MARKER BAND. THERE WERE SCRATCHES ON THE BALLOON DISTAL AND PROXIMAL TO THE PIN HOLE. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE RETURNED DEVICE ANALYSIS. IT WAS REPORTED THAT FOLLOWING DIFFICULTIES ADVANCING THE RX POWERSAIL THROUGH THE LESION FOR POST-DILATATION OF A STENT, A BALLOON RUPTURE WAS NOTED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PLACEMENT TECHNIQUE, MANUFACTURING, DEVICE SIZE SELECTION, OR ASSOCIATIVE DEVICE INTERACTION. IN THIS CASE, ALTHOUGH THERE WAS REPORTEDLY NO CALCIFICATION AT THE LESION, IT IS POSSIBLE THAT THE STENT IMPLANT BEING POST-DILATED CONTRIBUTED TO THE DIFFICULTIES ADVANCING. MEASUREMENTS OF THE RETURNED DEVICE BALLOON OUTER DIAMETER MET MANUFACTURING CRITERIA. FURTHERMORE, THERE WAS NO DAMAGE NOTED TO THE BALLOON OR TIP OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE DIFFICULTIES ADVANCING. THUS, A ROOT CAUSE FOR THE INABILITY TO ADVANCE CANNOT BE DETERMINED. ANALYSIS OF THE RETURNED DEVICE FOUND THAT ALONG WITH A PINHOLE RUPTURE, THERE WERE SCRATCHES TO THE SURFACE OF THE BALLOON. IT IS POSSIBLE THAT AS THE DIFFICULTIES ADVANCING THE POWERSAIL ACROSS THE LESION, THE STENT STRUTS CONTRIBUTED TO DAMAGING THE SURFACE OF THE BALLOON SUCH THAT IT RUPTURED. IN THIS CASE, THERE WAS NO REPORT OF DIFFICULTIES EXPERIENCED DURING PREPARATION, WHICH INDICATES THAT THE PINHOLE LIKELY WAS NOT PRESENT PRIOR TO THE PROCEDURE. THERE WAS CONTRAST VISIBLE IN THE BALLOON WHEN IT WAS RETURNED, SUGGESTING THAT THE DEVICE HAD BEEN INFLATED PRIOR TO THE RUPTURE. THUS, IT APPEARS THAT THE BALLOON SCRATCHES AND RUPTURE WERE THE RESULT OF THE OPERATIONAL CONTEXT OF THE DEVICE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO PREVIOUS INCIDENTS WITH THIS PART NUMBER /LOT NUMBER COMBINATION. THE PROFILE DIMENSIONS ON ALL CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE AT ABBOTT VASCULAR. ALL DILATATION CATHETERS UNDERGO 100% INSPECTION FOR LEAKS AND ARE VISUALLY INSPECTED BY MANUFACTURING. FURTHERMORE, A SAMPLE OF CATHETERS FROM EACH LOT IS DESTRUCTIVELY TESTED TO VERIFY THE RATED BURST PRESSURE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONAL: 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 RIGHT CORONARY ARTERY (RCA) WHICH HAD NO TORTUOSITY OR CALCIFICATION. THE POWERSAIL 3.0 X 8 MM WAS USED FOR POST-DILATATION; HOWEVER, THE PHYSICIAN HAD SOME DIFFICULTY CROSSING THE DEVICE AND THE GUIDING CATHETER CAME OFF A COUPLE OF TIMES WHEN ATTEMPTS WERE MADE TO CROSS THE LESION. THE POWERSAIL WAS UNABLE TO REACH THE LESION. IT WAS CONFIRMED THAT BLOOD WAS COMING INTO THE INDEFLATOR, SO USE THE POWERSAIL WAS DISCONTINUED TO A SUSPECTED BALLOON RUPTURE. WHEN AN ATTEMPT WAS MADE TO INFLATE THE POWERSAIL BALLOON OUTSIDE THE PATIENT'S BODY, IT WAS UNABLE TO INFLATE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERSAIL CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7052151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: RUNTHROUGH| LAUNCHER 6F JR 4.0 SH| GUIDING CATHETER:| FLOPPY