BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 19661783 · Received July 2, 2024

    Report

    Report Number
    9616099-2024-00219
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    May 28, 2024
    Report Date
    August 28, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    DQO
    UDI-DI
    10705032008273
    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, DURING PREOPERATIVE PREPARATION, A BROKEN HOLE WAS FOUND AT THE PROXIMAL END OF A 5F TEMPO PIGTAIL ANGIOGRAPHIC CATHETER AND SALINE SPRAYED OUT ABNORMALLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED CUSTOMER EVENT ¿CATHETER (BODY/SHAFT)- PUNCTURE/CUT¿ COULD NOT BE CONFIRMED. PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿TO PREVENT DAMAGE TO THE CATHETER TIP DURING REMOVAL FROM THE PACKAGE, GRASP THE HUB AND WITHDRAW THE CATHETER. TO PREVENT KINKING OF 5F (1.65 MM) AND SMALLER ANGIOGRAPHIC CATHETERS, AND SPECIFICALLY THE 4F (1.35 MM) INFINITI® PIGTAIL CATHETERS: STRAIGHTEN THE PIGTAIL CATHETER TIP ONLY WITH A DIAGNOSTIC GUIDEWIRE OR, IF APPLICABLE, WITH A TIP STRAIGHTENER. DO NOT STRAIGHTEN BY HAND.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, SECTION D.4 PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER HAS BEEN CORRECTED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, DURING PREOPERATIVE PREPARATION, A BROKEN HOLE WAS FOUND AT THE PROXIMAL END OF A 5F TEMPO PIGTAIL ANGIOGRAPHIC CATHETER AND SALINE SPRAYED OUT ABNORMALLY. THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. PLEASE UPGRADE THIS CASE TO AE. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552152 TEMPO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US CORP 18228232 10705032008273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN DEVICE