BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 23511527 · Received November 10, 2025

    Report

    Report Number
    9616099-2025-01823
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 12, 2025
    Report Date
    January 29, 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. THE CATH TEMPO 5F PIG 110CM SSH DEVICE WAS RECEIVED AS ONE NON-STERILE UNIT CONTAINED WITHIN A PLASTIC BAG AND WAS REMOVED FROM THE PACKAGING FOR EVALUATION. DURING VISUAL INSPECTION, THE STRAIN RELIEF WAS OBSERVED TO BE PARTIALLY PULVERIZED AND SEVERELY CRACKED, WITH PORTIONS REMAINING ADHERED TO THE CATHETER, AND THE CATHETER BODY EXHIBITED SEVERE CRACKING ALONG ITS ENTIRE LENGTH; YELLOWISH DISCOLORATION WAS ALSO NOTED ON THE CATHETER HUB, WITH NO OTHER ANOMALIES OBSERVED. FOLLOWING VISUAL INSPECTION, A MICROSCOPIC EXAMINATION WAS PERFORMED ON THE STRAIN RELIEF, CATHETER BODY, AND CATHETER HUB AREAS TO FURTHER ASSESS THE CONDITION OF THE STRAIN RELIEF AND THE OBSERVED DISCOLORATION. UNDER MICROSCOPIC REVIEW, THE STRAIN RELIEF WAS CONFIRMED TO BE PARTIALLY PULVERIZED AND SEVERELY CRACKED, THE CATHETER BODY EXHIBITED EXTENSIVE CRACKING ALONG ITS LENGTH, AND THE PARTIAL DISCOLORATION OBSERVED ON THE HUB DURING VISUAL INSPECTION WAS CONFIRMED; NO ADDITIONAL ANOMALIES WERE DETECTED. DURING THE PRODUCT EVALUATION OF THE REPORTED COMPLAINT, THE UNIT WAS CONFIRMED TO EXHIBIT DEGRADATION CHARACTERISTICS ON BOTH THE STRAIN RELIEF AND THE BODY OF THE CATHETER, AND BASED ON THESE FINDINGS, THE COMPLAINT WAS ESCALATED FOR FURTHER INVESTIGATION. THE REPORTED ¿CATHETER (BODY/SHAFT) ¿ DEGRADATION¿ AND ¿STRAIN RELIEF ¿ DEGRADATION¿ WAS OBSERVED DURING THE PRODUCT EVALUATION. 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 FOR EVALUATION.

    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
    15215 TEMPO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US CORP. 18422009 10705032008280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown