BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 1960493 · Received January 13, 2011

    Report

    Report Number
    3005099803-2011-00037
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    THIS EVENT HAS BEEN DEEMED NON-REPORTABLE BASED ON THE INVESTIGATION RESULTS THAT NO BENDING WAS PRESENT IN THE WORKING LENGTH OR EXPOSED CUT WIRE. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE WORKING LENGTH/DISTAL TIP WITH EXPOSED CUT WIRE WAS TWISTED. AN INVESTIGATION OF THE CANNULATING ORIENTATION OF THE DEVICE BY INSERTING THE DEVICE INTO AN ENDOSCOPE FOUND THAT THE INITIAL TIP ORIENTATION DID NOT MEET THE ORIENTATION SPECIFICATION OF BETWEEN 9:00 AM AND 2:00 PM DUE TO THE TWISTED WORKING LENGTH/DISTAL TIP. THE ORIENTATION OF THE DISTAL TIP COULD BE ADJUSTED LEFT OR RIGHT BY ROTATING THE HANDLE AND SET WITHIN ORIENTATION SPECIFICATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEVICE WOULD BOW PAST 90 DEGREES WHICH MEETS THE BOWING SPECIFICATION OF 90 DEGREE MINIMUM. THERE WAS NO BENDING IN THE WORKING LENGTH OR EXPOSED CUT WIRE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS BENT. THE COMPLAINT WAS NOT CONFIRMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS BENT WHEN REMOVED FROM IT'S PACKAGE. THERE WAS NO NOTED DAMAGE TO THE PACKAGE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX SPHINCTEROTOME.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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS BENT WHEN REMOVED FROM IT'S PACKAGE. THERE WAS NO NOTED DAMAGE TO THE PACKAGE ITSELF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DREAMTOME RX SPHINCTEROTOME.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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DREAMTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00584000 13735410

    Patients

    Seq Age Sex Outcome Treatment
    1