BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 24428031 · Received February 24, 2026

    Report

    Report Number
    9616099-2026-00301
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 23, 2026
    Report Date
    April 3, 2026
    Manufacturer
    CORDIS US. CORP
    Product Code
    DQO
    UDI-DI
    10705032008464
    PMA / PMN Number
    K973401
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, THE TIP OF A 5F TEMPO VERTEBRAL (VERT) 100 CM DIAGNOSTIC CATHETER WAS FOUND BROKEN IN THE PATIENT¿S DISTAL INTERNAL CAROTID ARTERY (ICA) DURING MID-USE. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE, NO EXCESSIVE TORQUING WAS REQUIRED, AND NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE; HOWEVER, THE DISTAL TIP BROKE, AND ALTHOUGH THERE WAS NO KINK IN THE AREA OF SEPARATION, THE USER HAD TO SNARE IT OUT WITH DIFFICULTY. THE EVENT OCCURRED DURING A DIAGNOSTIC CEREBRAL ANGIOGRAM; THE VESSEL WAS NOT TORTUOUS, AND THE CATHETER WAS NOT KINKED. THE LESION WAS NOT CALCIFIED, AND THE DEVICE WAS USED FOR A DIAGNOSTIC CEREBRAL ANGIOGRAM. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PATIENT REMAINED STABLE, THOUGH THE PROCESS WAS PROLONGED DUE TO RETRIEVAL DIFFICULTY. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS PROPERLY STORED AND OPENED IN A STERILE FIELD. THE DEVICE WAS RESTERILIZED AFTER THE PROCEDURE. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DIAGNOSTIC CATHETER WAS VISUALLY EVALUATED BASED ON ONE PHOTO PROVIDED FOR REVIEW. THE IMAGE SHOWS A SEPARATION AT THE PROXIMAL SECTION OF THE BRITE TIP, WITH AN IRREGULAR SEPARATION EDGE OBSERVED ON THE LARGER PORTION OF THE UNIT. NO ADDITIONAL OBSERVABLE DETAILS OR DISTINGUISHING FEATURES WERE IDENTIFIED IN THE IMAGE. THE AVAILABLE VISUAL INFORMATION IS INSUFFICIENT TO DETERMINE WHETHER THE OBSERVED CONDITION IS RELATED TO A MANUFACTURING OR DESIGN ISSUE, AND NO DEFINITIVE CONCLUSIONS CAN BE DRAWN BASED ON THE MATERIAL PROVIDED. THE REPORTED ¿BRITE TIP/DISTAL TIP ¿ SEPARATED¿ WAS OBSERVED DURING THE PHOTO ANALYSIS HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE WAS REPORTED TO HAVE BEEN USED WITHOUT RESISTANCE, EXCESSIVE TORQUE, KINKING, OR ADVANCEMENT DIFFICULTY, AND THE ANATOMY WAS DESCRIBED AS NON-TORTUOUS AND NON-CALCIFIED. HOWEVER, THE DISTAL TIP SEPARATED DURING WITHDRAWAL AND REQUIRED SNARE RETRIEVAL. GIVEN THE ABSENCE OF COMPLETE PROCEDURAL DETAILS AND THE LACK OF RETURNED PRODUCT FOR FURTHER EVALUATION, USE-RELATED FACTORS CANNOT BE EXCLUDED. THE INSTRUCTIONS FOR USE (IFU) STATE: ¿THIS PRODUCT IS INTENDED FOR USE BY PROFESSIONALS WHO HAVE BEEN TRAINED TO PERFORM DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THE REPORTED EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO ADDITIONAL ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    AS REPORTED, THE TIP OF A 5F TEMPO VERTEBRAL (VERT) 100 CM DIAGNOSTIC CATHETER WAS FOUND BROKEN IN THE PATIENT¿S DISTAL INTERNAL CAROTID ARTERY (ICA) DURING MID-USE. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE, NO EXCESSIVE TORQUEING WAS REQUIRED, AND NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE; HOWEVER, THE DISTAL TIP BROKE, AND ALTHOUGH THERE WAS NO KINK IN THE AREA OF SEPARATION, THE USER HAD TO SNARE IT OUT WITH DIFFICULTY. THE EVENT OCCURRED DURING A DIAGNOSTIC CEREBRAL ANGIOGRAM; THE VESSEL WAS NOT TORTUOUS AND THE CATHETER WAS NOT KINKED. THE LESION WAS NOT CALCIFIED, AND THE DEVICE WAS USED FOR A DIAGNOSTIC CEREBRAL ANGIOGRAM. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PATIENT REMAINED STABLE, THOUGH THE PROCESS WAS PROLONGED DUE TO RETRIEVAL DIFFICULTY. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS PROPERLY STORED AND OPENED IN A STERILE FIELD. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136796 TEMPO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US. CORP N/A 18421098 10705032008464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| R SNARE