BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR? PRO RX

    MDR report key: 4210626 · Received October 29, 2014

    Report

    Report Number
    3005099803-2014-03532
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K102082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE SHOWED THAT THE CATHETER WAS BROKEN. IT WAS ALSO NOTED DURING INSPECTION THAT THE CATHETER WAS STRETCHED. THE CAUSE OF THE CATHETER BREAK MOST LIKELY OCCURRED DURING DEVICE REMOVAL FROM THE SCOPE. THE STRETCH MARKS THAT WERE FOUND ON THE CATHETER ARE CONSISTENT WITH EXCESSIVE REMOVAL FORCE, AND SO IT IS PROBABLE THAT A STONE PRESENT IN THE BILE DUCT MAY HAVE BLOCKED THE CATHETER, OR THE CATHETER MAY HAVE BEEN CAUGHT BY THE SCOPE'S ELEVATOR. BASED ON THE INVESTIGATION RESULTS, THE MOST LIKELY ROOT CAUSE IS OPERATIONAL CONTEXT AS SOME PROCEDURAL FACTORS ENCOUNTERED MAY HAVE LIMITED THE PERFORMANCE OF THE DEVICE DURING THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) CATHETER BROKE. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER SNAPPED IN HALF WHILE THE TECHNICIAN WAS PULLING THE DEVICE FROM THE SCOPE. THE PROXIMAL END WAS REMOVED FROM THE SCOPE, AND THE DISTAL END OF THE DEVICE WAS REMOVED WITH THE SCOPE FROM THE PATIENT. THE REMAINING DISTAL PORTION OF THE CATHETER WAS PUSHED OUT OF THE SCOPE ONCE OUTSIDE THE PATIENT. IT WAS REPORTED THAT THERE WERE NO PIECES DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER SNAPPED IN HALF WHILE THE TECHNICIAN WAS PULLING THE DEVICE FROM THE SCOPE. THE PROXIMAL END WAS REMOVED FROM THE SCOPE, AND THE DISTAL END OF THE DEVICE WAS REMOVED WITH THE SCOPE FROM THE PATIENT. THE REMAINING DISTAL PORTION OF THE CATHETER WAS PUSHED OUT OF THE SCOPE ONCE OUTSIDE THE PATIENT. IT WAS REPORTED THAT NO PIECES DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691620 EXTRACTOR? PRO RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00547000 17144632

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR