BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH TEMPO 5

    MDR report key: 2873498 · Received December 14, 2012

    Report

    Report Number
    9616099-2012-00748
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K973401
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A SPERMATIC VEIN EMBOLIZATION PROCEDURE, THE DISTAL END OF A 5F TEMPO CATHETER SEPARATED IN THE PATIENT AND WAS SNARED OUT. THE PHYSICIAN GAINED ACCESS TO THE LEFT RENAL VEIN. HE INTRODUCED A 5F TEMPO DIAGNOSTIC SIM-2 CATHETER OVER A WIRE THAT WAS PLACED IN THE LEFT RENAL VEIN. THE PHYSICIAN PULLED OUT THE WIRE, SO THE CATHETER WILL RECEIVE ITS SHAPE; HE THEN TWISTED THE CATHETER IN ORDER TO TRY TO ACCESS THE SPERMATIC VEIN, WHILE TWISTING THE CATHETER THE PHYSICIAN NOTICED THAT THE CATHETER BROKE IN ITS DISTAL PART. THE PHYSICIAN PULLED OUT THE CATHETER AND NOTICED THAT PART OF ITS DISTAL SHAFT IS MISSING AND VISIBLE AT THE SPERMATIC VEIN. HE INTRODUCED A LONG SHEATH AND A SNARE AND SUCCESSFULLY SNARED THE BROKEN CATHETER PIECE AND PULLED IT OUT OF THE PATIENT'S BODY. THE PROCEDURE ENDED WITH NO FURTHER COMPLICATIONS, THE PATIENT IS STABLE. THERE WAS MODERATE VESSEL TORTUOSITY AND MODERATE ANGULATION. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THERE WAS ALSO NO RESISTANCE MET WHILE ADVANCING THE DEVICE. IT IS UNKNOWN IF EXCESSIVE TORQUING WAS REQUIRED OR IF RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. AN 8F SHEATH (BRAND UNKNOWN) AND A 0.035 COOK AMPLATZ GUIDEWIRE WERE USED IN THE PROCEDURE. THE PATIENT WAS A YOUNG MALE. THE DEVICE WAS RECEIVED AND THE PRELIMINARY EVALUATION INDICATED THAT IT WAS SEPARATED IN TWO AT 8CM FROM THE DISTAL TIP. FAL: ONE NON-STERILE CATH 5F 100CM WAS RECEIVED COILED INSIDE A PLASTIC BAG, WITH A SECTION SEPARATED AT 8CM FROM THE BODY, BOTH SECTIONS HAS BLOOD RESIDUES CONTAMINATION. BOTH SECTIONS HAD A BRAID WIRE EXPOSURE ON THE SEPARATION AREA. NO OTHER ANOMALIES WERE OBSERVED ON PROXIMAL SECTION. THE DISTAL END SECTION HAS DAMAGED ON THE TIP AREA, TWO DENTS, AND ON BODY SECTION HAS 5 CRACKS DISTRIBUTED ON 2CM AREA NEAR AT THE SEPARATION SECTION. SEE ATTACHED PICTURES. THE SEPARATION SECTION DID NOT HAVE EVIDENCE OF EXCESSIVE TORQUE. NO ADDITIONAL ANOMALIES WERE DETECTED. 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. SEM ANALYSIS REPORT INDICATES THE FOLLOWING RESULTS: "RESULTS SHOWED THAT THE CATHETER'S BODY PRESENTED EVIDENCE OF ELONGATION. IN ADDITION, THE BRAID WIRE PRESENTED EVIDENCE OF DUCTILE DIMPLES AND TWISTING. STRETCHING, TWISTING AND/ OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. CUTTING WAS DISCARDED AS A ROOT CAUSE SINCE NO CUTTING CHARACTERISTICS WERE OBSERVED IN THE BODY OF THE CATHETER AND/OR IN THE BRAID WIRE". OUTER DIAMETER (OD) OF THE RETURNED CATHETER WAS MEASURED NEAR TO SEPARATION SECTION AND WAS FOUND TO BE WITHIN SPECIFICATION. THE INTERNAL DIAMETER (ID) WAS NOT POSSIBLE TO MEASURE DUE TO THE WIRES THAT DID NOT PERMIT THE ACCESS TO ID. THE REPORTED CUSTOMER COMPLAINT OF CATHETER/BODY/SHAFT SEPARATION WAS CONFIRMED THROUGH FAILURE ANALYSIS. REVIEW OF THE INFORMATION PROVIDED AND THE ANALYSIS SUGGESTS THAT PROCEDURAL FACTORS, TWISTING OF THE CATHETER TO CANNULATE THE TARGET LESION, AND/OR VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW, THE ANALYSIS OR THE EVENT DESCRIPTION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A SPERMATIC VEIN EMBOLIZATION PROCEDURE, THE DISTAL END OF A 5F TEMPO CATHETER SEPARATED IN THE PATIENT AND WAS SNARED OUT. THE PHYSICIAN GAINED ACCESS TO THE LEFT RENAL VEIN. HE INTRODUCED A 5F TEMPO DIAGNOSTIC SIM-2 CATHETER OVER A WIRE THAT WAS PLACED IN THE LEFT RENAL VEIN. THE PHYSICIAN PULLED OUT THE WIRE, SO THE CATHETER WILL RECEIVE ITS SHAPE, HE THEN TWISTED THE CATHETER IN ORDER TO TRY TO ACCESS THE SPERMATIC VEIN , WHILE TWISTING THE CATHETER THE PHYSICIAN NOTICED THAT THE CATHETER BROKE IN ITS DISTAL PART. THE PHYSICIAN PULLED OUT THE CATHETER AND NOTICED THAT PART OF ITS DISTAL SHAFT IS MISSING AND VISIBLE AT THE SPERMATIC VEIN. HE INTRODUCED A LONG SHEATH AND A SNARE AND SUCCESSFULLY SNARED THE BROKEN CATHETER PIECE AND PULLED IT OUT OF THE PATIENT'S BODY. THE PROCEDURE ENDED WITH NO FURTHER COMPLICATIONS, THE PATIENT IS STABLE. THERE WAS MODERATE VESSEL TORTUOSITY AND MODERATE ANGULATION. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE OR DURING PREP. THERE WAS ALSO NO RESISTANCE MET WHILE ADVANCING THE DEVICE. IT IS UNKNOWN IF EXCESSIVE TORQUING WAS REQUIRED OR IF RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. AN 8F SHEATH (BRAND UNKNOWN) AND A 0.035 COOK AMPLATZ GUIDEWIRE WERE USED IN THE PROCEDURE. THE PATIENT WAS A YOUNG MALE. THE DEVICE WAS RECEIVED AND THE PRELIMINARY EVALUATION INDICATED THAT IT WAS SEPARATED IN TWO AT 8CM FROM THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH TEMPO 5 DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 15375178

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 0.035 COOK AMPLATZ GUIDEWIRE AND 8F SHEATH