BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH TEMPO 5

    MDR report key: 3231130 · Received July 17, 2013

    Report

    Report Number
    9616099-2013-00453
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K973401
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT 5FR TEMPO CATHETER TWISTED INSIDE A PATIENT AND BECAME DIFFICULT TO REMOVE. WHILE TRYING TO UNTWIST THE CATHETER IT SEPARATED, THE CATHETER REMAINED ON THE WIRE AND WAS REMOVED WITH A SNARE. THE CATHETER WAS BEING USED TO SELECT AN INTERNAL ARTERY INSIDE A FENESTRATED GRAFT. THE VESSEL WAS DESCRIBED AS SEVERELY ANGULATED, AND TORTUOUS. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTASIS VALVE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS REQUIRED. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE KINKED IN THE AREA OF SEPARATION. IT IS UNKNOWN IF RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY, A PROCEDURAL CD IS NOT AVAILABLE AND THE DEVICE WAS RETURNED FOR EVALUATION. FAL: A NON STERILE DIAGNOSTIC CATHETER 5F .038¿ 100 CM WAS RECEIVED COILED IN A PLASTIC BAG. THE BODY SHAFT OF CATHETER WAS RECEIVED SEPARATED IN TWO PIECES. CATHETER BODY SHAFT WAS FOUND SEPARATED AT 64.2 CM FROM HUB. ALSO, CATHETER BODY SHAFT WAS FOUND KINKED AT 9.0 CM FROM DISTAL END. DRY BLOOD RESIDUES OBSERVED. NO OTHER ANOMALIES WERE FOUND ON CATHETER. VISUAL ANALYSIS OF THE SEPARATED EDGES OF THE DEVICE SUGGESTED THAT TREMENDOUS FORCE WAS APPLIED. HOWEVER, IT WAS NOT POSSIBLE TO EVALUATE IF THE SEPARATION OF BODY SHAFT CATHETER AND KINK FOUND COULD BE DUE TO AN EXCESSIVE FORCE APPLIED CONDITION. PIECES OF COMPLAINT UNIT RECEIVED WERE SENT FOR FURTHER ANALYSIS TO SEM MICROSCOPIC ANALYSIS. THE OD AND ID OF RECEIVED CATHETER BODY SHAFT PIECES WERE MEASURED NEAR TO THE SEPARATION AND KINKED AREAS AND RESULTS WERE FOUND WITHIN SPECIFICATION. SEM ANALYSIS RESULTS SHOWED THAT THE RECEIVED CATHETER EXPERIENCED A TWISTING EVENT PRIOR TO THE SEPARATION. IN ADDITION, THE EXPOSED BRAID WIRES PRESENTED EVIDENCE OF DUCTILITY AND SMEARING ON THE SEPARATION SURFACES; BOTH CONDITIONS SUGGEST STRETCHING/ PULLING AND SMEARING EVENTS. NO EVIDENCE OF TOOL MARKS AROUND THE MENTIONED DAMAGES WAS OBSERVED; CUTTING WAS DISCARDED AS ROOT CAUSE SINCE THE MATERIAL DOES NOT PRESENT CUTTING CONDITIONS. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. THE REPORTED CUSTOMER COMPLAINT OF WITHDRAWAL DIFFICULTY COULD NOT BE EVALUATED; HOWEVER THE REPORTED CUSTOMER COMPLAINT OF CATHETER SEPARATION WAS CONFIRMED THROUGH FAILURE ANALYSIS. REVIEW OF THE INFORMATION PROVIDED AND THE ANALYSIS SUGGESTS THAT VESSEL CHARACTERISTICS (ANGULATED AND TORTUOUS) AND/OR PROCEDURAL FACTORS (EXCESSIVE TORQUING) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE ANALYSIS OR THE REPORTED EVENT TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE LOT NUMBER OF THIS DEVICE IS NOT CURRENTLY KNOWN. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT A 5F TEMP CATHETER WAS BEING USED TO SELECT AN INTERNAL ARTERY INSIDE A FENESTRATED GRAFT BUT THE CATHETER BECAME DIFFICULT TO REMOVE AND TWISTED. UPON ATTEMPTS TO UN-TWIST, THE DISTAL PORTION BROKE OFF. THIS WAS RETAINED ON THE WIRE AND REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331177 CATH TEMPO 5 DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SNARE