BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERTORQUE 5F MARKER BAND FLUSH CATHETER

    MDR report key: 2983460 · Received February 28, 2013

    Report

    Report Number
    9616099-2013-00105
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 28, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K915836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CATALOG NUMBER FOR THE CATHETER INVOLVED (SUPERTORQUE 5F MARKER BAND FLUSH CATHETER - (B)(4)) HAS BEEN UPDATED SINCE THE ORIGINALLY REPORTED CATALOG NUMBER (451503V5) REPRESENTS A TEMPO 5FR. FLUSH CATHETER WHICH DOES NOT HAVE MARKERBANDS ON THE CATHETER. SINCE THE COMPLAINT INVOLVES MARKERBANDS DISLODGING FROM THE CATHETERS THE TEMPO CATHETERS (451503V5/ LOT 15299679 AND 451503V5/ LOT 15255921) WILL BE OMITTED FROM THE COMPLAINT. PLEASE NOTE THAT SINCE THE EVENTS OCCURRED IN TWO SEPARATE PROCEDURES TWO SEPARATE CORDIS COMPLAINTS HAVE BEEN CREATED: (B)(4) - MEDWATCH REPORT #9616099-2013-00101, (B)(4) - MEDWATCH REPORT #9616099-2013-00105. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT SINCE THE EVENTS OCCURRED IN TWO SEPARATE PROCEDURES TWO SEPARATE CORDIS COMPLAINTS HAVE BEEN CREATED: (B)(4) - MEDWATCH REPORT #9616099-2013-00101. (B)(4) - MEDWATCH REPORT #9616099-2013-00105. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN AND NOTED THE FOLLOWING: THE PROCEDURE BEING PERFORMED WAS AN ENDOGRAFT PROCEDURE. THE PROCEDURE DID INVOLVE CHALLENGING ANATOMIES (TORTUOUS AND CALCIFIED), BUT THEY WERE NOT IN-ORDINARY AND CERTAINLY ANATOMIES THAT THE PHYSICIAN FELT SHOULD NOT PRESENT AN ISSUE FOR THE FLUSH CATHETER. THE PHYSICIAN USED AN OTW 8FR. SHEATH IN THE PROCEDURE. THE PHYSICIAN NOTED THAT THE MARKER BANDS BECAME LOOSE; BUT THEY DID NOT COME OFF THE CATHETER. NOTHING WAS LEFT BEHIND IN THE PATIENT. THE PHYSICIAN WAS NOT EXACTLY SURE WHEN THEY BECAME LOOSE. HE ONLY NOTICED THAT THE MARKERBANDS WERE LOOSE WHEN HE WITHDREW THE CATHETER. AS HE WAS PULLING BACK HE NOTICED SOME OF THE MARKERBANDS WERE MOVING TOWARDS EACH OTHER ('BUNCHING UP'). HE WOULD ESTIMATE THAT THE CATHETER WAS IN THE PATIENT FOR 15-20 MIN. NOTHING UNUSUAL OCCURRED. OTHERWISE THE CATHETERS WORKED FINE. THERE WAS NO ISSUE WITH THE FLUSH PORTION OF THEIR USE, JUST THE LOOSE MARKERBANDS. THERE WERE NO OTHER DIFFICULTIES OR UNUSUAL OCCURRENCES DURING THE PROCEDURE AND THE PATIENT IS FINE. THE PHYSICIAN RE-ITERATED THAT HE IS SURE NO MARKER BANDS WERE LEFT IN THE PATIENT. UPON FURTHER REVIEW THIS INFORMATION; THIS COMPLAINT DOES NOT MEET THE CRITERIA FOR MEDICAL DEVICE REPORTING. SINCE LOOSE MARKERBANDS ON THE CATHETER IS NOT A REPORTABLE EVENT ACCORDING TO FDA REPORTING GUIDELINES, THE MALFUNCTION HAS BEEN DEEMED NOT REPORTABLE. NO FURTHER REPORTS WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    AS REPORTED, AFTER USE OF A SUPERTORQUE 5F MARKER BAND FLUSH CATHETER A FEW OF THE GOLD MARKERS CAME OFF THE CATHETER AFTER THE PROCEDURE. NOTHING WAS LEFT BEHIND IN THE PATIENT AND NO HARM WAS DONE TO THE PATIENT. ACCORDING TO STAFF, IT WAS WITH TWO CATHETERS IN TWO SEPARATE PROCEDURES. . THEY SAID IT CAME OFF COMPLETELY AND OUTSIDE THE PATIENT. THE ACCOUNT WANTED TO RETURN DIFFERENT TYPES OF CATHETERS WITH DIFFERENT LOT NUMBERS. IT IS UNKNOWN AS TO EXACTLY WHICH CATALOG AND LOT IS INVOLVED. THE ACCOUNT PROVIDED A LIST OF CATHETERS THAT WERE TAKEN OFF THE SHELF: THE PRODUCT(S) COMPLAINT IS CATH MB 5F PIG 65 CM 8SH / CATH MB 5F PIG 65 CM 8SH / CATH MB 5F PIG 65 CM 8SH / CATH MB 5F PIG 110 CM 6SH / CATH MB 5F PIG 110 CM 6SH / CATH MB 5F PIG 110 CM 6SH / CATH TEMPO 5F PIG 65 CM 5SH / CATH TEMPO 5F PIG 65 CM 5SH; CAT# 532598C / 532598C / 532598C / 532598B / 532598B / 532598B / 451503V5 / 451503V5; LOT# 15658294 / 15576283 / 15601854 / 15646168 / 15643717 / 15596086 / 15299679 / 15255921. AS PER THE SALES REP, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86377 SUPERTORQUE 5F MARKER BAND FLUSH CATHETER DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1