BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1881527 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04353
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE BALLOON WAS TORN LONGITUDINALLY, CONFIRMING THE REPORTED EVENT OF BALLOON BURST. THERE WAS NO OTHER DAMAGE NOTED TO THE DEVICE. THE ROOT CAUSE HAS BEEN DETERMINED TO BE OPERATIONAL CONTEXT, AS THE FAILURE OCCURRED DUE TO SOME PROCEDURAL FACTORS SUCH AS CONTACT WITH A SHARP EXTERIOR SOURCE.

    Additional Manufacturer Narrative · 1

    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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO 3005099803-2010-04352 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CRE WIREGUIDED BALLOON DILATOR WAS USED IN A PYLORIC DILATION ON (B)(6), 2010 INVOLVING A (B)(6) OLD FEMALE PATIENT (PATIENT WEIGHT AND ID ARE UNKNOWN) ACCORDING TO THE COMPLAINANT, THE FIRST AND SECOND CRE BALLOONS POPPED DURING INFLATION. NO PIECES OF EITHER BALLOON DETACHED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD CRE BALLOON WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "FINE."

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO 3005099803-2010-04352 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A CRE WIREGUIDED BALLOON DILATOR WAS USED IN A PYLORIC DILATION ON (B)(6), 2010 INVOLVING A 50 YEAR OLD FEMALE PATIENT (PATIENT WEIGHT AND ID ARE UNKNOWN) ACCORDING TO THE COMPLAINANT, THE FIRST AND SECOND CRE BALLOONS POPPED DURING INFLATION. NO PIECES OF EITHER BALLOON DETACHED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD CRE BALLOON WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "FINE."

    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 M00558440 13418639

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR