BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH TEMPO 4F VER 135 DEGREE 100CM

    MDR report key: 10138799 · Received June 10, 2020

    Report

    Report Number
    9616099-2020-03729
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 10, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQO
    UDI-DI
    10705032007856
    PMA / PMN Number
    K973401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PHYSICIAN WAS READY TO PERFORM THE ANGIOGRAPHIC INTERVENTIONAL PROCEDURE AND INSPECT THE 4F 100CM VERTEBRAL (VER) 135 DEGREE TEMPO CATHETER, IT WAS FOUND THAT THE MIDDLE OF THE CATHETER WAS FRACTURED UPON REMOVAL OF THE PACKAGING. THEREFORE, THE PHYSICIAN USED ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELLING. THE DEVICE WAS STORED IN THE CATH LAB ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET LESION WAS THE RIGHT FEMORAL ARTERY. THE LESION WAS NOT CALCIFIED AND THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO STENOSIS AND THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS NOT FRACTURED INTO SEPARATE PIECES. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISCARDED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17884831 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER EVENT ¿CATHETER (BODY/SHAFT) - CRACKED - DURING PREP¿ COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. STORAGE/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PER THE IFU, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. DO NOT RESTERILIZE. EXPOSURE TO TEMPERATURES ABOVE 54OC (130OF) MAY DAMAGE THE CATHETER. EXERCISE CARE WHEN REMOVING GUIDEWIRES FROM MULTIPLE-CURVE CATHETERS. TO PREVENT KINKING OF 5F (1.65 MM) AND SMALLER ANGIOGRAPHIC CATHETERS; STRAIGHTEN THE PIGTAIL CATHETER TIP ONLY WITH A DIAGNOSTIC GUIDEWIRE OR, IF APPLICABLE, WITH A TIP STRAIGHTENER. DO NOT STRAIGHTEN BY HAND. TREAT ALL 4F CATHETERS AND SMALLER FRENCH SIZES WITH ULTIMATE CARE. THE PERFORMANCE OF THESE PRODUCTS MAY BE IMPAIRED IF NOT PROPERLY AND CAUTIOUSLY HANDLED DURING UNPACKING AND PREPARATION.¿ USERS ARE TRAINED TO INSPECT FOR KINKS AND BENDS, OR OTHER SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. NEITHER THE PHR REVIEW NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS THE PHYSICIAN WAS READY TO PERFORM THE ANGIOGRAPHIC INTERVENTIONAL PROCEDURE AND INSPECT THE 4F 100CM VERTEBRAL (VER) 135 DEGREE TEMPO CATHETER, IT WAS FOUND THAT THE MIDDLE OF THE CATHETER WAS FRACTURED UPON REMOVAL OF THE PACKAGING. THEREFORE, THE PHYSICIAN USED ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELLING. THE DEVICE WAS STORED IN THE CATH LAB ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET LESION WAS THE RIGHT FEMORAL ARTERY. THE LESION WAS NOT CALCIFIED AND THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO STENOSIS AND THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS NOT FRACTURED INTO SEPARATE PIECES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600395 CATH TEMPO 4F VER 135 DEGREE 100CM CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS CORPORATION 451414H0 17884831 10705032007856

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR