BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3021350 · Received March 26, 2013

    Report

    Report Number
    3005099803-2013-02054
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K110833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY MEDWATCH REPORT # (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST IT'S EXPIRY DATE. (B)(4) FOR THE REPORTED EVENT OF PROTECTIVE SLEEVE DETACHMENT. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD UNDERWENT A SERIES OF DILATATION PROCEDURES; THE EXACT NUMBER OF DILATATIONS IS UNKNOWN. DURING A DIAGNOSTIC IMAGING EXAM FOLLOWING THESE PROCEDURES, IT WAS NOTED THAT THE PROTECTOR CAP FROM A CRE BALLOON HAD BEEN LEFT INSIDE THE ESOPHAGUS OF THE PATIENT. THE PROTECTOR CAP WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT DURING THE INITIAL DILATATION PROCEDURE, THE PROTECTOR CAP WAS NOT REMOVED FROM THE BALLOON PRIOR TO INSERTION THROUGH THE SCOPE. HOWEVER, THERE WERE NO ISSUES WITH THE BALLOON DURING THE PROCEDURE AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS FINE. ADDITIONAL INFORMATION CONFIRMED THAT THIS EVENT OCCURRED DURING AN ESOPHAGEAL DILATION PROCEDURE ON (B)(6) 2013. IT WAS ALSO CONFIRMED THAT DURING THE PROCEDURE, THE PROTECTOR SLEEVE OF THE BALLOON WAS NOT REMOVED PRIOR TO INSERTION OF THE DEVICE. THE SLEEVE DETACHED INSIDE THE PATIENT AND THE PHYSICIAN HAD TO GO BACK IN TO RETRIEVE THE SLEEVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS NOT HARMED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD UNDERWENT A SERIES OF DILATATION PROCEDURES; THE EXACT NUMBER OF DILATATIONS IS UNKNOWN. DURING A DIAGNOSTIC IMAGING EXAM FOLLOWING THESE PROCEDURES, IT WAS NOTED THAT THE PROTECTOR CAP FROM A CRE BALLOON HAD BEEN LEFT INSIDE THE ESOPHAGUS OF THE PATIENT. THE PROTECTOR CAP WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT DURING THE INITIAL DILATATION PROCEDURE, THE PROTECTOR CAP WAS NOT REMOVED FROM THE BALLOON PRIOR TO INSERTION THROUGH THE SCOPE. HOWEVER, THERE WERE NO ISSUES WITH THE BALLOON DURING THE PROCEDURE AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123621 CRE? WIREGUIDED DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558420

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention