BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON

    MDR report key: 2153304 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02089
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE BALLOON PROFILE WAS RELAXED, THERE WAS NO PROTECTIVE SLEEVE PRESENT, THERE WAS NO STOPCOCK PRESENT, AND THE BALLOON WAS INFLATED TO THE THREE SPECIFIED PRESSURES 3, 5.5 AND 9 ATM. AT 5.5 ATM A LEAK WAS FOUND ON THE DISTAL SIDE OF THE BALLOON 5 MM FROM THE DISTAL TIP. ON FURTHER ANALYSIS, VIOLET DYE WAS USED DURING INFLATION TO CLEARLY IDENTIFY THE LOCATION OF THE LEAK. COMPLAINT CONFIRMED. CAUSE MAY BE DUE TO THE PRODUCTION PROCESS BECAUSE A SHORT BOND WAS VISIBLE IN THE RETURNED SAMPLE, AND IS POTENTIALLY A RESULT OF BOND LIFT AT THE DISTAL END OF THE BALLOON SLEEVE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS REPORTED FOR THE SAME LOT. THE (B)(6) 2008, 15-MONTH CRE BALLOONS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON (B)(6) 2008, THAT A CRE ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER DEVICE WAS USED FOR A DILATION PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, DURING DILATION THE BALLOON WAS INFLATED TO A DIAMETER OF 8 MM AND 9 MM WITHOUT DIFFICULTY. ONCE INFLATED TO 10 MM, THE BALLOON LOST PRESSURE (2 - 3 ATM), DEFLATING AIR INTO THE SYRINGE. A PERFORATION WAS OBSERVED ON THE BALLOON UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON KNQ BOSTON SCIENTIFIC CORPORATION M00558460 11512558

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK