BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ERCP CANNULA

    MDR report key: 2222131 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02915
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GCJ
    PMA / PMN Number
    K970054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED NO VISIBLE DEFECTS TO THE WORKING LENGTH. THE TIP WAS OBSERVED UNDER A MICROSCOPE AND NO TEAR/SPLIT WAS OBSERVED. THE BLUE PAINT BAND AT THE DISTAL TIP WAS SLIGHTLY PEELED, WHICH MAY HAVE CAUSED THE CUSTOMER TO STATE THAT THE TIP WAS TORN. A FUNCTIONAL EVALUATION WAS PERFORMED AND A 0.035" GUIDEWIRE COULD BE SMOOTHLY INSERTED THROUGH THE WORKING LENGTH OF THE DEVICE AND PAST THE DISTAL TIP. THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE TIP WAS TORN. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Additional Manufacturer Narrative · 1

    (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, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX PRE-CURVED ERCP CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN NOTED THAT THE TIP OF THE DEVICE WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX PRE-CURVED ERCP CANNULA. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INVESTIGATION RESULTS RECEIVED (B)(6) 2011. BASED ON THE INVESTIGATION RESULTS, WHICH INDICATE THAT NO DAMAGE WAS PRESENT TO THE TIP OF THE DEVICE, THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX PRE-CURVED ERCP CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN NOTED THAT THE TIP OF THE DEVICE WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX PRE-CURVED ERCP CANNULA. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX PRE-CURVED ERCP CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN NOTED THAT THE TIP OF THE DEVICE WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX PRE-CURVED ERCP CANNULA. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ERCP CANNULA LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - SPENCER M00545770 14221952

    Patients

    Seq Age Sex Outcome Treatment
    1