BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 19666289 · Received July 3, 2024

    Report

    Report Number
    9616099-2024-00220
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 28, 2024
    Report Date
    August 28, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    DQO
    UDI-DI
    10705032007740
    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

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: G3, G6, H2, H3, H6, AND H10. COMPLAINT CONCLUSION: AS REPORTED, THE TIP OF A 4F MULTI-PURPOSE (MP) A1100CM TEMPO DIAGNOSTIC CATHETER WAS FOUND TO BE SEPARATED INTO TWO PIECES. THE PRODUCT WAS DISCARDED, AND AN INTACT, UNIDENTIFIED CONTRAST CATHETER WAS USED INSTEAD. THERE WERE NO REPORTS OF PATIENT INJURY. THE ISSUE WAS DISCOVERED DURING INSPECTION BEFORE PERFORMING AN ANGIOGRAM. THE DEVICE WAS NOT INSERTED INTO THE PATIENT, AND THE PATIENT WAS UNHARMED. THE CATHETER HAD BEEN STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND THERE WERE NO DAMAGES TO THE PACKAGING. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB. A UNIT OF A CATHETER CATH TEMPO 4F MP A1 100CM WAS RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL TIP WAS SEPARATED FROM THE UNIT. THE DISTAL PORTION OF THE DEVICE WAS NOT RETURNED FOR THIS EVALUATION. INNER DIAMETER (ID) AND OUTER DIAMETER (OD) MEASUREMENTS WERE TAKEN NEAR THE DAMAGES AND WERE FOUND WITHIN SPECIFICATION. A HIGH MAGNIFICATION ANALYSIS WAS EXECUTED ON THE AFFECTED ZONE WHERE THE REPORTED SEPARATION WAS LOCATED. THE SURFACE WAS OBSERVED, AND IT WAS CONFIRMED THAT ELONGATIONS PATTERNS THAT COULD BE RELATED TO TENSILE FORCE EXPOSURE WERE OBSERVED ON THE SEPARATION BORDER. ADDITIONALLY SCRATCH MARKS WERE OBSERVED NEAR THE SEPARATION BORDER THAT COULD BE ATTRIBUTED TO INTERACTIONS WITH SHARP EDGED MATERIALS THAT MAY HAVE PROMOTE THE SEPARATION. THE FUSION UNION WAS EVALUATED, AND IT WAS OBSERVED THAT IT WAS NOT COMPROMISED DURING THE REPORTED EVENT. THE REPORTED ¿BRITE TIP/DISTAL TIP - SEPARATED¿ WAS CONFIRMED. A SEPARATION OCCURRED ON THE DISTAL PORTION OF THE UNIT AND IS DISTAL TO THE FUSION SECTION. DURING THE MICROSCOPIC ANALYSIS, SCRATCH MARKS AND ELONGATION PATTERNS THAT COULD BE RELATED TO ROUGH HANDLING AND PROCEDURAL FACTORS WERE OBSERVED NEAR THE SEPARATION BORDER. THEREFORE, IT COULD BE CONCLUDED THAT PROCEDURAL AND/OR 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, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. TREAT ALL 4F (1.35 MM) 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.¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE 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.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE TIP END OF A 4F MULTI-PURPOSE (MP) A1100CM TEMPO DIAGNOSTIC CATHETER WAS FOUND TO BE SEPARATED INTO TWO PIECES. THE PRODUCT WAS SUBSEQUENTLY DISCARDED, AND AN INTACT UNKNOWN CONTRAST CATHETER WAS USED. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE ISSUE WAS DISCOVERED PRIOR TO PERFORMING AN ANGIOGRAM ON THE PATIENT, UPON INSPECTION OF THE CATHETER, PRIOR TO DELIVERY OF THE DEVICE INTO THE BODY. THE PRODUCT WAS NOT INSERTED INTO THE PATIENT. THE PATIENT WAS NOT INJURED. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756220 TEMPO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US CORP NA 18262243 10705032007740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.