BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTION GOLD PROBE?

    MDR report key: 3851580 · Received June 5, 2014

    Report

    Report Number
    3005099803-2014-02137
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE DISTAL TIP DETACHED; THE GOLD TIP AND THE GUIDE TUBE WERE NOT RETURNED. RESISTANCE WAS FELT WHEN THE NEEDLE WAS ACTUATED, BUT ADDITIONAL FORCE WAS APPLIED AND THE NEEDLE EXTENDED, AT WHICH TIME THE NEEDLE WAS FOUND TO BE BENT. UPON DISSECTION OF THE DISTAL SECTION OF THE CATHETER, ADHESIVE REMNANTS WERE FOUND WITHIN THE INNER WALLS, INDICATING THE TIP WAS PROPERLY ATTACHED DURING MANUFACTURING. THE COMPLAINT WAS CONFIRMED; THE GOLD TIP WAS DETACHED AND WAS NOT RETURNED. ANATOMICAL/PROCEDURAL FACTORS LIKELY AFFECTED THE DEVICE INTEGRITY; THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DEVIATIONS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND. FROM THE INFORMATION AVAILABLE, IT APPEARS THE DEVICE WAS USED ACCORDING TO THE DFU/PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    THE EXACT EVENT/PROCEDURE DATE IS UNKNOWN, BUT WAS REPORTED TO BE APPROXIMATELY (B)(6) 2014. (B)(4) FOR THE REPORTED EVENT OF THE TIP DETACHING. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2014-02136 CAPTURES THE FIRST DEVICE AND #3005099803-2014-02137 CAPTURES THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO INJECTION GOLD PROBE DEVICES WERE USED IN THE PATIENT'S STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE TIP OF THE FIRST INJECTION GOLD PROBE DETACHED, BUT WAS HANGING BY THE WIRES. THE DEVICE WAS REMOVED AND A SECOND INJECTION GOLD PROBE WAS USED, HOWEVER; THE TIP DETACHED COMPLETELY AND FELL INTO THE PATIENT. THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2014-02136 CAPTURES THE FIRST DEVICE AND #3005099803-2014-02137 CAPTURES THE SECOND DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO INJECTION GOLD PROBE DEVICES WERE USED IN THE PATIENT'S STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE TIP OF THE FIRST INJECTION GOLD PROBE DETACHED, BUT WAS HANGING BY THE WIRES. THE DEVICE WAS REMOVED AND A SECOND INJECTION GOLD PROBE WAS USED, HOWEVER; THE TIP DETACHED COMPLETELY AND FELL INTO THE PATIENT. THE DETACHED PIECE WAS SUCCESSFULLY RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329385 INJECTION GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560150

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention