BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 2001427 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00511
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE CATHETER HAD BEEN CUT AND THE BALLOON HAD DETACHED. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE BALLOON WAS NOT RETURNED. IT IS POSSIBLE THAT WHEN, AS REPORTED, THE BALLOON RUPTURED DURING PROCEDURE, THE PHYSICIAN REMOVED THE CATHETER AND THE ENDOSCOPE TOGETHER AS A UNIT (AS INSTRUCTED IN THE DFU). THEN THE PHYSICIAN CUT THE CATHETER IN ORDER TO REMOVE IT FROM THE ENDOSCOPE. THE MOST PROBABLE ROOT CAUSE OF A BALLOON BURST/RUPTURED IS OPERATIONAL CONTEXT. THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE BALLOON. A DHR REVIEW WAS PERFORMED AND THERE WAS NO NON-CONFORMANCE RAISED FOR THE LOT. A REVIEW OF SIMILAR COMPLAINTS FOR THIS BATCH WAS CARRIED OUT AND NO OTHER COMPLAINT WAS FOUND.

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATING BALLOON WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE BALLOON BURST INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON WITH NO PATIENT COMPLICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WIREGUIDED DILATATIN BALLOON WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE BALLOON BURST INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON WITH NO PATIENT COMPLICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558500 0012827984

    Patients

    Seq Age Sex Outcome Treatment
    1