BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTION GOLD PROBE?

    MDR report key: 3961732 · Received July 28, 2014

    Report

    Report Number
    3005099803-2014-02552
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE DISTAL TIP DETACHED. THE DEVICE WAS ACTUATED AND THE TIP ALONG WITH THE HYPOTUBE GUIDE WERE DETACHED. UPON DISSECTION OF THE DISTAL SECTION OF THE CATHETER, ADHESIVE REMNANTS WERE EVIDENCED, INDICATING THE TIP WAS PROPERLY ATTACHED DURING MANUFACTURING. MOREOVER, THE NEEDLE WAS INSPECTED AND THE DEVICE DOES NOT HAVE THE NEEDLE BROKEN. THE COMPLAINT WAS CONFIRMED; THE GOLD TIP WAS DETACHED. 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

    PT AGE: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4). 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED IN THE FUNDUS OF THE PATIENT'S STOMACH DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE CERAMIC TIP OF THE PROBE AND PART OF THE NEEDLE SHAFT BROKE OFF AND LODGED INTO THE PATIENT¿S ESOPHAGUS. IT WAS REPORTED THAT THE DEVICE HAD BEEN USED SUCCESSFULLY 2-3 TIMES BEFORE THIS ISSUE OCCURRED. THE DETACHED PIECES WERE RETRIEVED USING BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE DEVICE WAS USED IN THE FUNDUS OF THE PATIENT'S STOMACH DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE CERAMIC TIP OF THE PROBE AND PART OF THE NEEDLE SHAFT BROKE OFF AND LODGED INTO THE PATIENT¿S ESOPHAGUS. IT WAS REPORTED THAT THE DEVICE HAD BEEN USED SUCCESSFULLY 2-3 TIMES BEFORE THIS ISSUE OCCURRED. THE DETACHED PIECES WERE RETRIEVED USING BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INJECTION GOLD PROBE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439823 INJECTION GOLD PROBE? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560150 16772212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention