BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 23511439 · Received November 10, 2025

    Report

    Report Number
    9616099-2025-01822
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 12, 2025
    Report Date
    January 31, 2026
    Manufacturer
    CORDIS US CORP.
    Product Code
    DQO
    UDI-DI
    10705032008280
    PMA / PMN Number
    K973401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE BODY OF 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. TWO STERILE UNITS OF ¿CATH TEMPO 5F PIG 110CM SSH¿ WERE RECEIVED IN THEIR ORIGINAL POUCH INSIDE A PLASTIC BAG; ONE UNIT CORRESPONDS TO THIS COMPLAINT AND THE OTHER CORRESPONDS TO (B)(4). THE UNIT ASSOCIATED WITH THIS COMPLAINT WAS UNPACKED TO PERFORM A VISUAL INSPECTION, DURING WHICH THE POUCH SEALS WERE CONFIRMED INTACT AND STERILITY WAS NOT COMPROMISED; UNITS WERE IDENTIFIED AS UNIT NUMBER ONE FOR (B)(4) AND UNIT NUMBER TWO FOR (B)(4). VISUAL INSPECTION OF CATHETER NUMBER ONE IDENTIFIED A DEGRADATION CONDITION ON THE CATHETER BODY, WHILE THE STRAIN RELIEF DID NOT PRESENT A DEGRADATION CONDITION AND NO OTHER OUTSTANDING DETAILS WERE OBSERVED. BASED ON THE CONFIRMED DEGRADATION CHARACTERISTICS OBSERVED ON THE BODY OF THE UNITS, AND WITH NO ADDITIONAL ANOMALIES DETECTED DURING THE EVALUATION, THE COMPLAINT WAS ESCALATED FOR FURTHER INVESTIGATION. THE REPORTED ¿CATHETER (BODY/SHAFT) ¿ DEGRADATION¿ WAS OBSERVED DURING THE PRODUCT EVALUATION WHILE ¿STRAIN RELIEF ¿ DEGRADATION¿ WAS NOT. BASED ON THE AVAILABLE INFORMATION, THE SPECIFIC CAUSE OF THE DEGRADATION COULD NOT BE DETERMINED. POTENTIAL CONTRIBUTING FACTORS INCLUDE STORAGE OR HANDLING CONDITIONS WITHIN THE REPORTING FACILITY OR FACTORS ASSOCIATED WITH THE MANUFACTURING PROCESS OF THE UNIT. USERS ARE TRAINED TO INSPECT PRODUCTS FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE, AND ANY PRODUCT SHOWING DAMAGE IS NOT TO BE USED. THE PRODUCT LABELING INCLUDES INFORMATION FOR SAFETY INTENDED TO MAKE USERS AWARE OF SUCH RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. DO NOT EXPOSE TO ORGANIC SOLVENTS.¿ WHILE THIS GUIDANCE MITIGATES RISKS ASSOCIATED WITH STORAGE AND HANDLING, IT DOES NOT ELIMINATE THE POTENTIAL FOR DEGRADATION. BECAUSE A POTENTIAL LINK TO THE MANUFACTURING PROCESS COULD NOT BE EXCLUDED, AN INVESTIGATION HAS BEEN INITIATED TO FURTHER EVALUATE POTENTIAL CONTRIBUTING FACTORS AND IMPLEMENT FURTHER ACTIONS AS APPROPRIATE. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    THE 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 · 0

    THE DEVICE WAS RETURNED.

    Description of Event or Problem · 0

    AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICES WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273653 TEMPO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US CORP. 18263474 10705032008280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown