BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL TUBES & ACCESSORIES

    MDR report key: 1923940 · Received December 14, 2010

    Report

    Report Number
    3005099803-2010-05108
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K945618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4): THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, AND / OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED NO DAMAGE ON THE WORKING LENGTH OF THE DEVICE WITH RESPECT TO TEARS OR KINKS. THE TIP OF THE DEVICE WAS KINKED/BENT. A FUNCTIONAL EVALUATION WAS PERFORMED BY INSERTING A 0.035" GUIDEWIRE FROM THE PROXIMAL END OF THE DEVICE AND IT WAS FOUND THAT THE GUIDEWIRE EXITED THE DISTAL TIP OF THE DEVICE WITH MINIMUM RESISTANCE. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE TIP OF THE DEVICE WAS KINKED PRIOR TO USE. BASED ON INVESTIGATION RESULTS, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO REMOVE STONES IN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, WHEN THE TANDEM XL WAS INSERTED INTO THE CHANNEL OF THE ENDOSCOPE, THE PHYSICIAN FOUND THAT THE TIP WAS KINKED MAKING CANNULATION DIFFICULT. NO DAMAGE WAS NOTED TO THE PACKAGING MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER TANDEM XL CANNULA. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TANDEM XL CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO REMOVE STONES IN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, WHEN THE TANDEM XL WAS INSERTED INTO THE CHANNEL OF THE ENDOSCOPE, THE PHYSICIAN FOUND THAT THE TIP WAS KINKED MAKING CANNULATION DIFFICULT. NO DAMAGE WAS NOTED TO THE PACKAGING MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER TANDEM XL CANNULA. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GASTROINTESTINAL TUBES & ACCESSORIES TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00535700

    Patients

    Seq Age Sex Outcome Treatment
    1