BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAPCATH 5 FR

    MDR report key: 807047 · Received January 8, 2007

    Report

    Report Number
    1927197-2007-00001
    Event Type
    Other
    Date Received
    January 8, 2007
    Date of Event
    December 8, 2006
    Report Date
    January 4, 2007
    Manufacturer
    CARDIOCOMMAND, INC.
    Product Code
    MGD
    PMA / PMN Number
    p860008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF MANUFACTURING RECORDS FOR THIS LOT SHOWED NO PROBLEM THAT WOULD BE RELATED TO THIS REPORT. EXAMINATION OF THE RETURNED CATHETER SHOWED THAT TWO ELECTRODES WERE ATTACHED AT THE TIME OF MANUFACTURE. PHOTOS OF THE AREA, OF THE CATHETER, WHERE THE ONE ELECTRODE IS MISSING SHOW CLEAR EVIDENCE THAT AN ELECTRODE WAS PRESENT AT THE TIME OF MANUFACTURE. FURTHERMORE, IF THE CATHETER HAD BEEN PLACED INTO THE PT WITH THE ELECTRODE MISSING THE PT WOULD NOT HAVE BEEN ABLE TO HAVE BEEN PACED. DATE: 12/13/06. SUBJECT: INSPECTION AND ANALYSIS OF TAPCATH CATHETER INVOLVED IN THE COMPLAINT FROM MEDICAL CENTER. TODAY, I EXAMINED THE TAPCATH 5 FR CATHETER WHICH WAS RETURNED TO US BY MEDICAL CENTER, THE PERSON MAKING THE COMPLAINT VIA TELEPHONE LAST WEEK AND WAS INTERVIEWED LATER THAT DAY ON THE PHONE. AT THE TIME OF THE INTERVIEW, I ASKED HER TO GET THE PHYSICIAN IN CHARGE OF THE PACING OF THE INFANT IN WHICH THE TAPCATH WAS BEING USED TO CALL ME SO THAT I COULD ASK SOME QUESTIONS. THE REPORTED INFORMATION DURING OUR PHONE INTERVIEW WAS THAT THEY (MEDICAL CENTER) USED THE TAPCATH FREQUENTLY AND THAT THE PHYSICIAN IN CHARGE WAS AN ELECTRO PHYSIOLOGIST AND VERY EXPERIENCED WITH TRANS-ESOPHAGEAL PACING AND THE USE OF OUR TAPCATH CATHETER. AS OF THIS DAY, I HAVE NOT BEEN CONTACTED, BUT SHE HAS PROVIDED THE ANSWERS TO OUR QUESTIONS AFTER RESEARCHING THEM FOR US AND SAID ANSWERS WERE INCLUDED IN WRITTEN FORM ALONG WITH THE TAPCATH WHICH WAS RETURNED TO US FOR INSPECTION. THIS PRODUCT COMPLAINT ORIGINATED BECAUSE THE TAPCATH 5 FR PACING AND RECORDING CATHETER CEASED TO FUNCTION PROPERLY WHILE PACING A SMALL CHILD. THE CATHETER WAS THEN REMOVED FROM THE CHILD, AND IT WAS OBSERVED THAT THE DISTAL STAINLESS STEEL ELECTRODE WAS MISSING. THE CATHETER IS A BIPOLAR CATHETER AND THE ABSENCE OF ONE ELECTRODE MADE PACING IMPOSSIBLE. THE INFANT WAS X-RAYED, BUT HERE WAS NO SIGN OF THE MISSING METAL ELECTRODE DETECTED ON THE FILM. THE INFANT WAS IN THE PEDIATRIC ICU AND THE PACING BEING DONE SEEMED TO ME, FROM THE DISCUSSION WITH HER, TO BE OF LONGER DURATION THAN THE ONE HOUR SPECIFIED IN OUR INSTRUCTIONS. ADDITIONALLY, THE CATHETER SEEMED FROM THEIR DESCRIPTION TO BE BEING USED IN A LIFE SUPPORT ROLE RATHER THAN THE DIAGNOSTIC AND THERAPEUTIC ROLES FOR WHICH IT IS INTENDED. THE SUBSEQUENT RETURN OF THE CATHETER, AND THE WRITTEN DESCRIPTION ACCOMPANYING IT OF HOW IT WAS BEING USED MADE VERY CLEAR THE LIFE SUPPORT USE AND THE PROTRACTED DURATION OF THE PACING, SINCE THEY HAD RESEARCHED THE SITUATION AND PROVIDED US DETAILED INFORMATION IN THE FORM OF A WRITTEN SUMMARY. THE WRITTEN REPORT SUBMITTED ACCOMPANYING THE TAPCATH INDICATED THAT THE DEVICE HAD BEEN USED FOR CARDIAC PACING IN THE ICU FOR A TOTAL OF 50 HOURS. ALONG WITH THE TAPCATH IN THE ESOPHAGUS WAS ALSO AN NG TUBE. THE REASON FOR PACING WAS ATRIAL TACHYCARDIA. THE TAPCATH WAS INITIALLY PLACED SOMETIME (EXACT TIME NOT SPECIFIED IN THE REPORT) AND PACING WAS BEGUN AT A STRENGTH OF 20 MA. PACING AT 20 MA WAS CONTINUED FOR THE FIRST 36 HOURS OF PACING AND THEN WAS REDUCED TO 14 FOR THE NEXT 12 HOURS. ON THE DAY AFTER PLACEMENT AND INITIATION OF ESOPHAGEAL CARDIAC PACING AN X-RAY WAS MADE AND SHOWED THE ESOPHAGEAL CATHETER AND ELECTRODES BOTH INTACT. THE NEXT DAY, IN THE AM ANOTHER X-RAY WAS MADE AND SHOWED THE DISTAL ELECTRODE MISSING FROM THE CATHETER. THERE WAS NO REPORT OF ANY METALLIC BODY OTHER THAN THE PROXIMAL ELECTRODE SHOWN ON THE LATER FILM. THE RETURNED CATHETER WAS ENCLOSED WITHIN A ZIP-LOCK TYPE BAG. VISIBLE THROUGH THE CLEAR PLASTIC BAG WAS THE PROXIMAL ELECTRODE AND THE TIP OF THE WIRE WHICH WAS ORIGINALLY WELDED TO THE NOW MISSING DISTAL ELECTRODE. ALSO CLEARLY VISIBLE WERE THE TWO INDENTATIONS IN THE BODY OF THE CATHETER WHICH RESULT FROM THE CRIMPING OF THE ELECTRODE ENDS INTO THE CATHETER BODY DURING THE MANUFACTURING PROCESS. GIVEN THE HISTORY OF VERY PROTRACTED ESOPHAGEAL PACING OF THE INFANT, AND THE PHYSICAL APPEARANCE OF THE CATHETER, I BELIEVE STRONGLY THAT THE DISTAL ELECTRODE WAS DEFINITELY PRESENT WHEN THE CATHETER WAS FIRST INSERTED. THS WAS NOT A CASE OF A MISSING ELECTROLDE DUE TO A MANUFACTURING DEFECT. I STRONGLY BELIEVE THIS DUE TO THE CLEAR PRESENCE OF ELECTRODE CRIMP MARKS IN THE BODY OF THE CATHETER BODY AT THE SPECIFIED LOCATION OF THE DISTAL ELECTRODE, AND FURTHER TO THE FACT THAT THE CATHETER SUCCESSFULLY PACED THE PT FOR THE REPORTED 50 HOURS, AT WHICH TIME PACING WAS REPORTED AS NOT POSSIBLE. (THE CATHETER WAS THEN REMOVED AND A NEW ONE PLACED WITH RESUMPTION OF SUCCESSFUL PACING ACCORDING TO THE INTERVIEW.) THE DISAPPEARANCE OF THE ELECTRODE IS EXPLAINED, I BELIEVE BY THE ELECTROCHEMICAL REACTION AT THE ANODE (DISTAL ELECTRODE) WHICH RESULTED IN THE ELECTROLYTIC DISSOLUTION OF THE STAINLESS STEEL ELECTRODE DURING THE 50 HOURS THAT IT WAS USED FOR PACING. THE ABSENCE OF METAL FRAGMENTS ON X-RAY WOULD SUPPORT THE BELIEF THAT THE ELECTRODE WAS ELECTROLYTICALLY CONSUMED DURING THE 50 HOURS OF PACING. THEY STATED THAT ANOTHER CATHETER WAS INSERTED AFTER REMOVAL OF THE NON-FUNCTIONAL CATHETER, AND PACING WAS RESUMED. WHEN SPECIFICALLY ASKED IF THERE WAS PT INJURY, THEY REPORTED THAT THERE WAS NO PT INJURY.

    Description of Event or Problem · 1

    CATHETER INSERTED IN PT IN 2006 AND WAS PACING. X-RAY THE NEXT DAY SHOWED ELECTRODE INTACT ON CATHETER. PRODUCT WAS PACING. CATHETER CHECKED AM ON THE FOLLOWING DAY, ONE ELECTRODE WAS ABSENT. DEVICE HAD BEEN USED FOR PACING FOR UP TO 50 HOURS. PRODUCT LABEL STATES, "TOTAL DURATION OF PACING SHOULD NOT EXCEED ONE HOUR." IT IS ASSUMED THAT ELECTROCHEMICAL REACTION AT THE ANODE (DISTAL ELECTRODE) RESULTED IN THE ELECTROLYTIC DISSOLUTION OF THE STAINLESS STEEL ELECTRODE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPCATH 5 FR ESOPHAGEAL PACING CATHETER MGD CARDIOCOMMAND, INC. 180 0616303

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO