BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR? PRO RX

    MDR report key: 4100637 · Received September 19, 2014

    Report

    Report Number
    3005099803-2014-03030
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K102082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. REPORTED EVENT OF DISTAL TIP DETACHED. 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE DISTAL TIP OF THE CATHETER WAS MISSING AND THE CATHETER SHAFT WAS STRETCHED. THE SHAFT STRETCH STARTED AT 215CM FROM THE BALLOON HUB AND THE DISTAL TIP HAD BECOME DETACHED 220.5CM FROM THE DISTAL TIP. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE OF DISTAL TIP DETACHED/SEPARATED WAS CONFIRMED. THOUGH THE EVENT OF CATHETER DIFFICULTY REMOVING/WITHDRAWING CANNOT BE CONFIRMED, THE DAMAGE TO THE CATHETER SHAFT IS CONSISTENT WITH THIS EVENT. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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.

    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) IN THE DUODENUM PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE PASSING THE BALLOON DOWN THE SCOPE BUT WAS ABLE TO EXIT THE SCOPE. THE PHYSICIAN THOUGHT THAT SOMETHING WAS WRONG AND REMOVED IT FROM THE PATIENT. THE BALLOON DID NOT PASS INTO THE DUCT. HOWEVER, WHEN HE TRIED TO PULL THE BALLOON BACK INTO THE SCOPE AND SIGNIFICANT RESISTANCE WAS MET. UPON REMOVAL IT WAS NOTED THAT THE CATHETER HAD SPLIT AND THE TIP OF BALLOON HAD SEPARATED FROM THE CATHETER. REPORTEDLY, THE TIP OF THE BALLOON WAS NOT RETRIEVED AND LEFT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE.

    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) IN THE DUODENUM PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE PASSING THE BALLOON DOWN THE SCOPE BUT WAS ABLE TO EXIT THE SCOPE. THE PHYSICIAN THOUGHT THAT SOMETHING WAS WRONG AND REMOVED IT FROM THE PATIENT. THE BALLOON DID NOT PASS INTO THE DUCT. HOWEVER, WHEN HE TRIED TO PULL THE BALLOON BACK INTO THE SCOPE AND SIGNIFICANT RESISTANCE WAS MET. UPON REMOVAL IT WAS NOTED THAT THE CATHETER HAD SPLIT AND THE TIP OF BALLOON HAD SEPARATED FROM THE CATHETER. REPORTEDLY, THE TIP OF THE BALLOON WAS NOT RETRIEVED AND LEFT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582521 EXTRACTOR? PRO RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00547000 0017096386

    Patients

    Seq Age Sex Outcome Treatment
    1