BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 2070421 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01367
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE WORKING LENGTH TO BE TWISTED. NO HOLE OR TEAR WAS PRESENT IN THE WORKING LENGTH OF THE DEVICE. A FUNCTIONAL EVALUATION WAS PERFORMED BY INJECTING WATER THROUGH THE DEVICE. WATER SPURTED OUT AT THE TIP INITIALLY AND THEN BACKFLOW WAS OBSERVED FILLING THE GUIDEWIRE LUMEN AND FLOWING OUT FROM THE ENDING OF THE OPEN GUIDEWIRE CHANNEL NEAR THE DISTAL TIP. THIS RESULT IS ANTICIPATED AS THE GUIDEWIRE LUMEN AND THE CONTRAST LUMEN ARE FUSED INTO A SINGLE LUMEN WITHIN THE EXTRUSION. POOLING OF CONTRAST MEDIA MAY HAVE BEEN PERCEIVED AS A LEAK BY THE USER. THE INVESTIGATION REVEALED THAT THERE WAS NO HOLE OR TEAR: BASED ON THIS INFORMATION, THIS IS NO LONGER AN MDR-REPORTABLE SCENARIO. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE ACCOUNT FLUSHED THE CATHETER OF THE DEVICE WITH CONTRAST SOLUTION. HOWEVER, THE CONTRAST LEAKED FROM THE WORKING LENGTH OF THE DEVICE. UPON INSPECTION, A SMALL HOLE WAS NOTED IN THE CATHETER LOCATED AT THE DISTAL END OF THE C-CHANNEL NEAR THE BROWN MARKER BAND. THE PRELOADED JAGWIRE WAS LOADED WITHIN THE DEVICE DURING FLUSHING. 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 TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(4), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, THE ACCOUNT FLUSHED THE CATHETER OF THE DEVICE WITH CONTRAST SOLUTION. HOWEVER, THE CONTRAST LEAKED FROM THE WORKING LENGTH OF THE DEVICE. UPON INSPECTION, A SMALL HOLE WAS NOTED IN THE CATHETER LOCATED AT THE DISTAL END OF THE C-CHANNEL NEAR THE BROWN MARKER BAND. THE PRELOADED JAGWIRE WAS LOADED WITHIN THE DEVICE DURING FLUSHING. 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 M00584060 14019138

    Patients

    Seq Age Sex Outcome Treatment
    1