BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMTOME RX SPHINCTEROTOME

    MDR report key: 1831889 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03712
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 2, 2010
    Report Date
    August 20, 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

    PATIENT'S EXACT AGE IS NOT KNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. DEVICE COMPONENT CODE "WIRE" (B)(4) RELATES TO DEVICE CODE "MATERIAL TWISTED" (B)(4) FOR THE REPORTED EVENT OF WIRE TWISTED. DEVICE EVALUATION: A VISUAL EXAMINATION REVEALED THAT THE DISTAL TIP WITH EXPOSED CUT WIRE WAS TWISTED, EXPOSED WIRE WAS MISALIGNED AND THERE WAS EXCESS SLACK IN THE EXPOSED CUT WIRE. ANALYZING THE DISTAL TIP, IT APPEARS THAT THE TWISTED DISTAL TIP AND TWISTED/ MISALIGNED EXPOSED WIRE ARE LIKELY DUE TO INCORRECT WRAPPING AND/OR PLACEMENT OF THE FORMING MANDREL DURING TOME PACKAGING AND SUBSEQUENT SETTING OF THE DISTAL TIP CURVE DURING STERILIZATION. A FUNCTIONAL EVALUATION FOUND THAT THE DEGREE OF DEVICE BOWING MEETS THE BOWING SPECIFICATION, BUT THE BOWING WAS NOT IN PLANE DUE TO THE TWISTED DISTAL TIP/ MISALIGNED CUT WIRE. ANALYZING THE MISALIGNED EXPOSED CUTTING WIRE AT THE DISTAL TIP WITH THE HANDLE PUSHED OUT, IT APPEARS THAT DURING THE HANDLE ASSEMBLY, THE CUTTING WIRE WAS NOT COMPLETELY PULLED INTO THE HANDLE TO REMOVE THE SLACK AND THUS HAD EXCESS BOW. THE WORKING LENGTH (EXTRUSION) WAS MEASURED AND MEETS THE LENGTH SPECIFICATION. THE CUTTING WIRE AT THE HANDLE WAS FOUND TO BE SECURED FIRMLY BY THE 2-IN-1 CONNECTOR/ ALUMINUM DISK INDICATING THERE WAS NO WIRE SLIPPAGE. INCORRECT SETTING OF THE CUT WIRE TENSION DURING HANDLE ASSEMBLY COMBINED WITH INCORRECT WRAPPING OF THE TOME DEVICE DURING PACKAGING COULD CAUSE MISALIGNMENT/ TWISTING OF THE EXPOSED CUT WIRE. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE EXPOSED CUT WIRE AT THE DISTAL TIP WAS TWISTED. THE INCORRECT WIRE TENSIONING, DEVICE WRAPPING AND/OR SETTING OF THE FORMING MANDREL LIKELY CAUSED THE TWISTED DISTAL TIP AND CUT WIRE/ EXCESS SLACK AND THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DREAMTOME RX SPHINCTEROTOME WAS BEING PREPARED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, OUTSIDE THE PATIENT, THE DEVICE WAS OPENED AND REMOVED FROM THE PACKAGING. THE CUTTING WIRE WAS OBSERVED TO BE TWISTED AROUND THE CATHETER OF THE DEVICE. THE ACCOUNT REPORTED NO VISIBLE DAMAGE TO THE PACKAGING AND THE STERILE BARRIER HAD NOT BEEN COMPROMISED. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS THAT INDICATED THE BOWING WAS NOT IN PLANE.

    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 M00584050 0013504573

    Patients

    Seq Age Sex Outcome Treatment
    1