BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERTORQUE 5F MARKER BAND FLUSH CATHETER

    MDR report key: 2983473 · Received February 28, 2013

    Report

    Report Number
    9616099-2013-00101
    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 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 MARKER BANDS 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.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM A SALES REPRESENTATIVE INDICATED THAT THE GOLD MARKER BANDS OF A 5FR SUPERTORQUE FLUSH CATHETER CAME OFF 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: CATH MB 5F PIG 65CM 8SH / CATH MB 5F PIG 65CM 8SH / CATH MB 5F PIG 65CM 8SH / CATH MB 5F PIG 110CM 6SH / CATH MB 5F PIG 110CM 6SH / CATH MB 5F PIG 110CM 6SH / CATH TEMPO 5F PIG 65CM 5SH / CATH TEMPO 5F PIG 65CM 5SH. PLEASE NOTE THAT THE TEMPO CATHETERS DO NOT HAVE MARKER BANDS. AS PER THE SALES REP, NO ADDITIONAL INFORMATION IS AVAILABLE. THE CATHETERS INVOLVED WERE NOT SAVED, AND NOBODY FROM THE LAB CAN CONFIRM THE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE MEDICAL DIRECTOR AND DIRECTOR OF RESEARCH AND DEVELOPMENT FROM CORDIS CORPORATION TO SPEAK WITH THE PHYSICIAN INVOLVED, HOWEVER THESE INQUIRES HAVE GONE UNANSWERED. FAL: NINE (9) STERILE 5F (SUPER TORQUE - PIG) DIAGNOSTIC CATHETERS WITH MARKER BANDS WERE RECEIVED INSIDE THEIR ORIGINAL SEALED POUCH. NO STRETCHING OR ELONGATION MARKS WERE FOUND ALONG THE 9 CATHETERS. NONE OF THE MARKER BANDS (20 MB PER CATHETER) OF EACH CATHETER WERE FOUND DISLODGED; ALL OF THEM WERE NOTED IN THEIR ORIGINAL POSITION. NO OTHER ANOMALIES WERE NOTED IN THE NINE RETURNED DEVICES. ALL NINE (9) CATHETERS WERE INSPECTED UNDER A MICROSCOPE AT 16X OF MAGNIFICATION AND NO ANOMALIES WERE OBSERVED IN THE MARKER BAND. A 0.038" CORDIS GUIDE WIRE (LAB SAMPLE) WAS INSERTED INTO THE CATHETERS AND NO RESISTANCE WAS FELT DURING INSERTION TEST. THE INNER DIAMETER OF EACH DISTAL TIP WAS MEASURED AND THE VALUES WERE FOUND WITHIN SPECIFICATION. THE OUTER DIAMETER OF THREE SECTIONS OF EACH CATHETER TIP SECTION WAS MEASURED FROM THE HUB MOVING DISTALLY AND VALUES WERE WITHIN SPECIFICATION. ALL THE MEASUREMENTS WERE FOUND WITHIN SPECIFICATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED CUSTOMER COMPLAINT OF MARKER BANDS DISLODGED WAS NOT CONFIRMED THROUGH FAILURE ANALYSIS, AS THE CATHETERS WERE RECEIVED WITH THE MARKER BANDS INTACT AND IN PROPER POSITION. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE DIFFICULTIES REPORTED BY THE CUSTOMER. THERE IS NOTHING IN THE ANALYSIS OR THE DEVICE HISTORY REPORT REVIEW SO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. (B)(4)

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CATALOG NUMBER FOR THE CATHETERS INVOLVED HAS BEEN UPDATED SINCE THE ORIGINALLY REPORTED CATALOG NUMBER ((B)(4)) 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 ((B)(4)) 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). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    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 5 F PIG 65 CM 8 SH / CATH MB 5 F PIG 65 CM 8 SH / CATH MB 5 F PIG 65 CM 8 SH / CATH MB 5 F PIG 110 CM 6 SH / CATH MB 5 F PIG 110 CM 6 SH / CATH MB 5 F PIG 110 CM 6 SH / CATH TEMPO 5 F PIG 65 CM 5 SH / CATH TEMPO 5 F PIG 65 CM 5 SH; 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
    86560 SUPERTORQUE 5F MARKER BAND FLUSH CATHETER DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1