BEUDAMED
    FDA Adverse Event Death Summary report: N

    DP6 PROBE

    MDR report key: 2033563 · Received March 22, 2011

    Report

    Report Number
    9680933-2009-00008
    Event Type
    Death
    Date Received
    March 22, 2011
    Date of Event
    April 17, 2009
    Report Date
    March 18, 2011
    Manufacturer
    DELTEX MEDICAL LIMITED
    Product Code
    IYN
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: IT IS APPARENT THAT THE REPORTED USE OF THE DP6 PROBE WAS UNEVENTFUL AND AT THE TIME OF USE, THERE WAS NO REASON TO CONCLUDE THAT OESOPHAGEAL PERFORATION HAD OCCURRED. AT NO TIME WAS ANY SIGNIFICANT RESISTANCE ENCOUNTERED WHICH WOULD HAVE SUGGESTED CONCERN THAT THE PROBE HAD PUNCTURED THE OESOPHAGEAL WALL. THE EFFORTS TO FOCUS THE PROBE HAD ONLY INCLUDED ROTATION OF THE PROBE AND SMALL UP AND DOWN DEPTH MOVEMENTS. THE PROBE WAS NOT WITHDRAWN NOR RE-INSERTED DURING THIS PROCEDURE. OBSERVATION OF THE PROBE AFTER USE DID NOT REVEAL ANY DAMAGE OR DEFECTS OF ANY KIND. THE PROBE WAS ALSO REPORTED NOT TO HAVE BLOOD ON THE TIP OR SHAFT. THE POSSIBILITY THAT THE OESOPHAGUS HAD PRE-EXISTING DISEASE NEEDS TO BE INVESTIGATED FURTHER. DELTEX MEDICAL DOES NOT ACCEPT CAUSALITY FOR THIS NEAR INCIDENT.

    Description of Event or Problem · 1

    REPORTED COMPLAINT: DELTEX MEDICAL WAS MADE AWARE OF THIS POTENTIAL ADVERSE EVENT BY DR (B)(6). THE FIRST REPORT WAS SOME TIME AFTER THE DATE OF THE PROCEDURE AND WAS PROVIDED VERBALLY TO (B)(4) ((B)(4), DELTEX MEDICAL, LTD). AT THE TIME, THE ADVICE WAS INFORMATIVE THAT THERE MAY BE CAUSE FOR CONCERN WITH A PT WHO UNDERWENT MAJOR SURGERY WHERE AN OESOPHAGEAL DOPPLER PROBE HAD BEEN INSERTED. INITIAL E-MAIL COMMUNICATIONS WERE DELAYED AS THE INITIAL E-MAIL ADDRESS PROVIDED TO DELTEX MEDICAL WAS INCORRECT AND RELATED TO A (B)(6) IN (B)(6). SUBSEQUENTLY, THE CORRECT E-MAIL ADDRESS WAS OBTAINED DIRECTLY FROM THE ANAESTHETICS SECRETARY OF THE HOSPITAL. FOLLOWING TELEPHONE COMMUNICATIONS AND E-MAIL CORRESPONDENCE TO CLARIFY EVENTS DELTEX MEDICAL ADVISED THE (B)(6) ON (B)(6) OF A POTENTIAL ADVERSE EVENT WHILST USING A DELTEX MEDICAL DP6 OESOPHAGEAL DOPPLER PROBE. CIRCUMSTANCE OF THE INCIDENT: AN (B)(6) MALE ((B)(6)) WAS ADMITTED TO (B)(6) HOSPITAL FOR ELECTIVE SURGERY FOR THE REMOVAL OF A SUSPECTED CANCEROUS TUMOR. THE SURGEON WAS MR (B)(6), MD CONSULTANT LAPAROSCOPIC AND COLORECTAL SURGEON AND THE ANAESTHETIST WAS DR (B)(6), CONSULTANT ANESTHETIST. DR (B)(6) HAS ADVISED US THAT DUE TO THE AGE OF THE PT, AND AS HE WAS UNDER-GOING MAJOR SURGERY, DR (B)(6) BELIEVE IT IMPORTANT TO PROVIDE FLUID OPTIMISATION. CLINICAL EVIDENCE STRONGLY SUPPORTS USE OF THIS PROCEDURE IN THIS GROUP OF PATIENTS. A DELTEX MEDICAL DP6 PROBE WAS INSERTED ORALLY INTO THE PT'S OESOPHAGUS. THE PROCEDURE WAS UNREMARKABLE AND NO SIGNIFICANT RESISTANCE TO INSERTION WAS NOTED. DR (B)(6) REPORTED THAT IT PROVED DIFFICULT TO FIND A DESCENDING AORTIC WAVEFORM AND AFTER A PERIOD OF FOCUSING, USE OF THE PROBE WAS ABANDONED. DR (B)(6) REPORTS THAT THE PT WAS HAEMODYNAMICALLY STABLE AND THUS, FELT THAT THERE WAS NO NEED TO CONTINUE TO ATTEMPT TO FOCUS THE PROBE. THE PROBE WAS LEFT IN PLACE AND THE SURGERY PROCEEDED WITHOUT FURTHER ATTEMPTS TO FLUID OPTIMISE THE PT USING THE DEVICE. AFTER THE PROCEDURE, THE DP6 PROBE WAS REMOVED AND DISPOSED OF AS WAS ITS PACKAGING. NO OTHER DEVICES WERE INSERTED INTO THE OESOPHAGUS DURING THE PROCEDURE. PRIOR TO SURGERY, THE PT UNDER WENT A CT SCAN. WE HAVE BEEN ADVISED THAT THE SCAN SHOWED THE OESOPHAGUS TO BE NORMAL, ALTHOUGH THE AREA COVERED BY THE SCAN WAS NOT STATED. PT CONDITION POSTOPERATIVELY: TWO DAYS POST OPERATIVELY, A SECOND CT SCAN REVEALED LEAKAGE FROM THE LOWER THIRD OF THE OESOPHAGUS. THE OESOPHAGUS WAS REPORTED TO APPEAR DILATED. ENDOSCOPY REVEALED THREE POSSIBLE LESIONS IN THE MID TO LOWER THIRD OF THE OESOPHAGUS. A SECOND SURGICAL PROCEDURE WAS PERFORMED TO REPAIR THE REGION OF THE OESOPHAGUS WITH AN OESOPHAGEAL STENT. THE PT WE ARE ADVISED WAS ADMITTED TO THE ICU AND SOME TIME LATER DIED. A POST MORTEM HAS BEEN PERFORMED WHICH REVEALED TWO TRACHEO-OESOPHAGEAL FISTULAE. THE CAUSE OF THE DEATH WE UNDERSTAND WAS SEPTICAEMIA RELATED TO THE TRACHEO-OESOPHAGEAL FISTULAE AND PERFORATION OF THE OESOPHAGUS. COMMENTS: DR (B)(6) HAS ADVISED DELTEX MEDICAL THAT THE FOCUSING PROCEDURE WAS UNREMARKABLE AT THE TIME, SAVE THE DIFFICULTY IN OBTAINING A SIGNAL. THE EFFORTS TO FOCUS THE PROBE INCLUDED ROTATION OF THE PROBE AND SMALL UP AND DOWN DEPTH MOVEMENTS. THE PROBE WAS NOT WITHDRAWN NOR RE-INSERTED DURING THIS PROCEDURE. AT NO TIME DID DR (B)(6) ENCOUNTER ANY SIGNIFICANT RESISTANCE WHICH WOULD HAVE LEAD HER TO BE CONCERNED THAT THE PROBE HAD PUNCTURED THE OESOPHAGEAL WALL. DR (B)(6) REPORTS THAT THE PROBE WAS BRIEFLY EXAMINED ON REMOVAL AND DID NOT APPEAR TO BE DAMAGED OR DEFECTIVE IN ANY WAY. THE PROBE WAS ALSO REPORTED NOT TO HAVE BLOOD ON THE TIP OR SHAFT. AT THIS TIME, DELTEX MEDICAL IS UNCERTAIN AS TO THE EXACT POSITION OF THE PERFORATIONS SAVE THAT THEY WERE IN THE MID TO LOWER THIRD OF THE OESOPHAGUS. ESTABLISHING THE EXACT POSITION COULD BE IMPORTANT IN ASCERTAINING WHETHER THEY WERE WITHIN THE RANGE OF THE PROBE TIP POSITION. INFO TO DATE SUGGESTS THE PERFORATIONS TO BE BELOW THE NORMAL TIP POSITION. DR (B)(6) HAS ADVISED THAT SHE HAD NO REASON TO CONCLUDE THAT THE TRACHEO-OESOPHAGEAL FISTULAE WERE RELATED TO THE USE OF THE PROBE. DELTEX MEDICAL HAS NOT VIEWED A COPY OF THE POST MORTEM AT THIS TIME SO THE POSITION OF THESE FISTULAE IS UNK. AS THE FISTULAE EXTENDED FROM THE TRACHEA TO THE OESOPHAGUS, IT WOULD BE EXPECTED THAT THEY WERE UNRELATED TO THE PREVIOUSLY REPORTED PERFORATIONS. AS THE FISTULAE WERE NOT REPORTED IN EITHER THE CT SCANS PERFORMED BEFORE OR AFTER SURGERY, IT IS UNCLEAR WHETHER THEY DEVELOPED DURING HOSPITALIZATION OR WHETHER THE CT SCANS HAD INCLUDED THIS REGION OF THE PT'S THORAX. IT IS IMPORTANT TO KNOW THEIR EXACT LOCATION AND POSSIBLE AETIOLOGY. TRACHEO-OESOPHAGEAL FISTULAE ARE MOST COMMONLY REPORTED TO BE CONGENITAL; HOWEVER, THEIR DEVELOPMENT MAY BE RELATED TO SEPTICAEMIA OR CANCEROUS TISSUE OF THE OESOPHAGUS OR BOTH. CLARIFICATION OF THIS IS IMPORTANT AS IT SUGGESTS THERE MAY HAVE BEEN UNDETECTED DISEASE OF THE OESOPHAGUS. THE DELTEX MEDICAL DP6 PROBE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFO, WHICH MAY BE RELEVANT TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DP6 PROBE IYN DELTEX MEDICAL LIMITED DP6

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death