BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOTOME RX SPHINCTEROTOME

    MDR report key: 1647402 · Received March 31, 2010

    Report

    Report Number
    3005099803-2010-01658
    Event Type
    Death
    Date Received
    March 31, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNS
    PMA / PMN Number
    K013153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED BY THE COMPLAINANT REVEALED THAT THE PATIENT WAS BEING TREATED FOR CHOLEDOCOLITHIASIS. ALL THE STONES WERE REMOVED. THE PATIENT CODED DURING THE PROCEDURE DUE TO THE LACK OF OXYGEN CAUSED BY AN OBSTRUCTION OR ISSUE RELATED TO THE ANESTHESIA. THE COMPLAINANT WOULD NOT OFFER INFORMATION REGARDING THE PATIENT¿S MEDICAL HISTORY. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE. A REVIEW OF THE CUSTOMER'S SHIPMENT HISTORY REVEALED THREE LOTS THAT WERE RECENTLY SHIPPED TO THIS CUSTOMER (PRIOR TO THE EVENT DATE). A REVIEW OF THE DEVICE HISTORY RECORD OF EACH LOT REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B) (4)

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FIVE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-01653, 3005099803-2010-01651, 3005099803-2010-01654 AND 3005099803-2010-01670 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIRECT VISUALIZATION PROBE, A SPYSCOPE ACCESS AND DELIVERY CATHETER, AN AUTOTOME RX SPHINCTEROTOME, A DREAMWIRE, AND A EXTRACTOR RX RETRIEVAL BALLOON WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B) (6) 2010. DURING THE ERCP PROCEDURE, A DREAMWIRE GUIDEWIRE WAS INSERTED INTO THE DUODENAL SCOPE AND POSITIONED WITHIN THE COMMON BILE DUCT. THE PHYSICIAN THEN PASSED AN AUTOTOME DEVICE OVER THE DREAMWIRE. THE AUTOTOME WAS REMOVED FROM THE PATIENT. AN EXTRACTOR BALLOON WAS USED TO REMOVE SEVERAL STONES FROM THE COMMON BILE DUCT. THE EXTRACTOR BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT. THE SPYGLASS SYSTEM WAS THEN USED TO INSPECT THE COMMON BILE DUCT. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE POSITIONED WITHIN THE DUCT; THE DUCT WAS OBSERVED TO BE NORMAL WITH MINOR DEBRIS. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE REMOVED FROM THE PATIENT. AT THIS TIME, THE PATIENT DESATURATED AND A CODE WAS CALLED BY THE ANESTHESIOLOGIST. THE PATIENT EXPIRED IMMEDIATELY AFTER THE REMOVAL OF THE DEVICE. NO ABNORMALITIES OR DEVICE MALFUNCTIONS WERE REPORTED DURING THE ERCP PROCEDURE. AT THIS TIME, THE FACILITY DOES NOT ATTRIBUTE THE PATIENT DEATH TO ANY BSC PRODUCT USED DURING THE CASE. THE FACILITY WOULD NOT RELEASE THE AUTOPSY REPORT; HOWEVER, THEY STATED THAT THE REPORT INDICATED "NO KNOWN CAUSE OF DEATH" AND THEY SAW NOTHING IN THE AUTOPSY TO INDICATE THAT THERE WERE ANY ISSUES IN THE AREA THAT THE ERCP WAS PERFORMED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FIVE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-01653, 3005099803-2010-01651, 3005099803-2010-01654 AND 3005099803-2010-01670 FOR THE OTHER ASSOCIATED DEVICE INFORMATION.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIRECT VISUALIZATION PROBE, A SPYSCOPE ACCESS AND DELIVERY CATHETER, AN AUTOTOME RX SPHINCTEROTOME, A DREAMWIRE, AND A EXTRACTOR RX RETRIEVAL BALLOON WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B) (6) 2010. DURING THE ERCP PROCEDURE, A DREAMWIRE GUIDEWIRE WAS INSERTED INTO THE DUODENAL SCOPE AND POSITIONED WITHIN THE COMMON BILE DUCT. THE PHYSICIAN THEN PASSED AN AUTOTOME DEVICE OVER THE DREAMWIRE. THE AUTOTOME WAS REMOVED FROM THE PATIENT. AN EXTRACTOR BALLOON WAS USED TO REMOVE SEVERAL STONES FROM THE COMMON BILE DUCT. THE EXTRACTOR BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT.THE SPYGLASS SYSTEM WAS THEN USED TO INSPECT THE COMMON BILE DUCT. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE POSITIONED WITHIN THE DUCT; THE DUCT WAS OBSERVED TO BE NORMAL WITH MINOR DEBRIS. THE SPYGLASS PROBE AND ACCESS & DELIVERY CATHETER WERE REMOVED FROM THE PATIENT. AT THIS TIME, THE PATIENT DESATURATED AND A CODE WAS CALLED BY THE ANESTHESIOLOGIST. THE PATIENT EXPIRED IMMEDIATELY AFTER THE REMOVAL OF THE DEVICE. NO ABNORMALITIES OR DEVICE MALFUNCTIONS WERE REPORTED DURING THE ERCP PROCEDURE. AT THIS TIME, THE FACILITY DOES NOT ATTRIBUTE THE PATIENT DEATH TO ANY BSC PRODUCT USED DURING THE CASE. THE FACILITY WOULD NOT RELEASE THE AUTOPSY REPORT; HOWEVER, THEY STATED THAT THE REPORT INDICATED "NO KNOWN CAUSE OF DEATH" AND THEY SAW NOTHING IN THE AUTOPSY TO INDICATE THAT THERE WERE ANY ISSUES IN THE AREA THAT THE ERCP WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOTOME RX SPHINCTEROTOME UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - SPENCER M00545170

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death