BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 2011049 · Received March 8, 2011

    Report

    Report Number
    3005099803-2011-00785
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED TWO KINKS IN THE CATHETER OF THE DEVICE. THE EXIT RAMP WAS FOUND NO LONGER IN ITS DOWNWARD POSITION. INSPECTION OF THE CATHETER ALSO REVEALED DAMAGE TO THE C-CHANNEL. THE DAMAGED C-CHANNEL CREATED A JAGGED EDGE. FUNCTIONAL TESTING WAS PERFORMED; A 0.035 INCH GUIDEWIRE WAS LOADED AT THE INTRODUCER AND EXITED AT THE DISTAL TIP OF THE DEVICE SUCCESSFULLY, HOWEVER RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT DUE TO THE KINKS IN THE CATHETER AND DAMAGE IN THE C-CHANNEL. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THE COMPLAINT THAT THERE WAS A REMNANT PIECE OF PLASTIC COVERING THE GUIDEWIRE EXIT PORT WAS NOT CONFIRMED; IT IS POSSIBLE THE EXIT RAMP IN THE UPWARD POSITION WAS MISTAKEN FOR A REMNANT PIECE OF PLASTIC. ALTHOUGH THE INVESTIGATION COULD NOT CONFIRM THE REPORTED EVENT, THIS COMPLAINT WILL REMAIN AN MDR REPORTABLE EVENT BASED ON JAGGED EDGES NOTED IN THE CATHETER OF THE DEVICE. THE DAMAGE NOTED TO THE CATHETER OF THE DEVICE MAY BE DUE TO EXCESSIVE FORCE USED IN REMOVING THE GUIDEWIRE FROM THE C-CHANNEL. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE DEVICE. 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 SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. 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 ON (B)(4), 2011 THAT AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN (B)(6) MALE PATIENT ON (B)(6), 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR PAINLESS JAUNDICE DUE TO SUSPECTED STRICTURE OF THE COMMON BILE DUCT. DURING THE PROCEDURE, THE EXTRACTOR RX BALLOON WAS ADVANCED OVER A HYDRA JAGWIRE GUIDEWIRE (BSC, UNKNOWN UPN), HOWEVER THE GUIDEWIRE WOULD NOT EXIT AT THE EXIT RAMP OF THE EXTRACTOR RX BALLOON; THE GUIDEWIRE CONTINUED TO RUN UP THE C-CHANNEL OF THE CATHETER. IT WAS REPORTED THAT IT APPEARED THERE WAS A REMNANT PIECE OF PLASTIC COVERING THE GUIDEWIRE EXIT RAMP; THE PIECE OF PLASTIC WAS BLOCKING THE GUIDEWIRE. IT WAS ALSO REPORTED THAT THIS PIECE OF PLASTIC WAS "STILL SLIGHTLY CONNECTED TO THE CATHETER". THE GUIDEWIRE WAS LIFTED OUT OF THE C-CHANNEL AND THE BALLOON WAS THEN ADVANCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS EXTRACTOR RX RETRIEVAL BALLOON. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE HYDRA JAGWIRE GUIDEWIRE USED IN THIS PROCEDURE. 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. PLEASE NOTE: THE ORIGIN OF THE "REMNANT PIECE OF PLASTIC" IS CURRENTLY UNKNOWN AND IT WAS REPORTED THE PLASTIC WAS "SLIGHTLY CONNECTED" TO THE CATHETER. BASED ON AVAILABLE INFORMATION, IT IS UNKNOWN IF THERE WAS A POTENTIAL FOR THIS FRAGMENT TO DETACH INSIDE THE PATIENT, THEREFORE THE EVENT HAS BEEN DEEMED A MDR REPORTABLE EVENT. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN (B)(6), MALE PATIENT ON (B)(6), 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT WAS BEING TREATED FOR PAINLESS JAUNDICE DUE TO SUSPECTED STRICTURE OF THE COMMON BILE DUCT. DURING THE PROCEDURE, THE EXTRACTOR RX BALLOON WAS ADVANCED OVER A HYDRA JAGWIRE GUIDEWIRE (BSC, UNKNOWN UPN), HOWEVER THE GUIDEWIRE WOULD NOT EXIT AT THE EXIT RAMP OF THE EXTRACTOR RX BALLOON; THE GUIDEWIRE CONTINUED TO RUN UP THE C-CHANNEL OF THE CATHETER. IT WAS REPORTED THAT IT APPEARED THERE WAS A REMNANT PIECE OF PLASTIC COVERING THE GUIDEWIRE EXIT RAMP; THE PIECE OF PLASTIC WAS BLOCKING THE GUIDEWIRE. IT WAS ALSO REPORTED THAT THIS PIECE OF PLASTIC WAS "STILL SLIGHTLY CONNECTED TO THE CATHETER". THE GUIDEWIRE WAS LIFTED OUT OF THE C-CHANNEL AND THE BALLOON WAS THEN ADVANCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS EXTRACTOR RX RETRIEVAL BALLOON. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE HYDRA JAGWIRE GUIDEWIRE USED IN THIS PROCEDURE. 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. PLEASE NOTE: THE ORIGIN OF THE "REMNANT PIECE OF PLASTIC" IS CURRENTLY UNKNOWN AND IT WAS REPORTED THE PLASTIC WAS "SLIGHTLY CONNECTED" TO THE CATHETER. BASED ON AVAILABLE INFORMATION, IT IS UNKNOWN IF THERE WAS A POTENTIAL FOR THIS FRAGMENT TO DETACH INSIDE THE PATIENT, THEREFORE THE EVENT HAS BEEN DEEMED A MDR REPORTABLE EVENT. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00546900 14050144

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR OLYMPUS ENDOSCOPE (UNKNOWN MODEL/UPN)| HYDRA JAGWIRE GUIDEWIRE (BSC, UNKNOWN UPN)