BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRATOME RX SPHINCTEROTOME

    MDR report key: 1832644 · Received September 13, 2010

    Report

    Report Number
    3005099803-2010-03889
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH AND DISTAL TIP WERE TWISTED. IN ADDITION, THE CLOSED EXTRUSION AT THE DISTAL TIP WAS RIPPED. THE RIP EXISTED FROM THE POINT WHERE THE GUIDE WIRE CHANNEL ENDS, TO THE TIP, TEARING OPEN THE CLOSED EXTRUSION THROUGH THE DISTAL TIP AND SPLITTING THE TIP. A FUNCTIONAL EVALUATION FOUND THAT CONTINUITY EXISTED BETWEEN THE 2-IN-1 CONNECTOR AND THE EXPOSED CUTTING WIRE, WHICH ALLOWED PROPER CONDUCTIVITY ACROSS THE DEVICE. THE RESISTANCE ACROSS THE 2-IN-1 CONNECTOR AND THE CUTTING WIRE MEASURED WITHIN THE CUTTING RESISTIVITY SPECIFICATION. THE LENGTH OF THE EXPOSED CUTTING WIRE WAS WITHIN SPECIFICATION AND THE DEVICE TIP BOWED WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED UNIT WAS NOT CONSISTENT WITH THE CUSTOMER COMPLAINT THAT THE DEVICE WOULD NOT TRANSMIT CURRENT. THE COMPLAINT WAS NOT CONFIRMED. DURING MANUFACTURING, TOME DEVICES ARE 100% INSPECTED SO THE RIPPED EXTRUSION AND DISTAL TIP, LIKELY OCCURRED DUE TO PROCEDURAL FACTORS. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE CONDITION OF THE RETURNED COMPLAINT DEVICE IS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    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 HYDRATOME SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WOULD NOT TRANSMIT CURRENT. THE ACTIVE CORD AND GROUNDING PADS WERE DOUBLE CHECKED AND THE DEVICE WOULD STILL NOT TRANSMIT CURRENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME 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 HYDRATOME SPHINCTEROTOME WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WOULD NOT TRANSMIT CURRENT. THE ACTIVE CORD AND GROUNDING PADS WERE DOUBLE CHECKED AND THE DEVICE WOULD STILL NOT TRANSMIT CURRENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HYDRATOME 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 HYDRATOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00583040 13483308

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR