BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCS CATH EXTEN 45CM 1200PSI

    MDR report key: 1833154 · Received September 14, 2010

    Report

    Report Number
    9616099-2010-00681
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED DURING THE PROCEDURE: A RADIFOCUS GUIDEWIRE, A TERUMO GUIDING CATHETER AND A TERUMO SHEATH. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ADDITIONAL TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE PRODUCT WAS RETURNED FOR ANALYSIS. DURING ANGIOGRAPHY, THE WHITE INSERT INSIDE THE METAL CONNECTOR OF THE CATHETER EXTENSION TUBING BROKE AND CAME OFF DURING POWER INJECTION. NO PATIENT INJURY OCCURRED. THE EXTENSION TUBING WAS CONNECTING A NAMIC POWER INJECTOR AND AN ANGIOGRAPHIC CATHETER; CONTRAST WAS INJECTED AT 829PSI. THE PROCEDURE WAS FINISHED SUCCESSFULLY USING A DIFFERENT CATHETER EXTENSION TUBE. THE PHYSICIAN COMMENTED THAT DURING THE PURGING OF AIR, HE DID NOT HIT THE UNIT AT THE SITE WHERE IT BROKE. BOTH UNITS USED IN THE PROCEDURE WERE RETURNED. THE UNIT THAT WAS USED TO COMPLETE THE PROCEDURE WAS WITHOUT ANOMALIES. THE COMPLAINT UNIT HAD PRESENTED A BROKEN INSERT AT THE MID SECTION. SEM ANALYSIS SHOWED THAT THE FAILURE SURFACE EXHIBITS CHARACTERISTICS OF FRACTURE AND SMEARING. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION WAS NOTED IN THE FAILURE SITE. NO VISUAL EVIDENCE OF CUTTING WAS NOTED. THE EXACT CAUSE OF THE FRACTURE/SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED DURING PRODUCT ANALYSIS. DPRA (B)(4) HAS BEEN OPENED TO ADDRESS THIS TYPE OF FAILURE IN THE CATHETER EXTENSION FAMILY. THIS ADDITIONAL COMPLAINT DOES NOT CHANGE THE OCCURRENCE RATE OR SEVERITY LEVEL ESTABLISHED IN THE INVESTIGATION. NO ADDITIONAL ACTIONS ARE NEEDED AT THIS TIME.

    Description of Event or Problem · 1

    CORONARY ANGIOGRAPHY WAS BEING CONDUCTED. THE CATHETER EXTENSION TUBE WAS ATTACHED BETWEEN A NAMIC ANGIOGRAPHIC INJECTOR AND AN ANGIOGRAPHIC CATHETER AND CONTRAST MEDIUM WAS INJECTED AT 829PSI FOR 8.2SEC. HOWEVER, THE WHITE INSERT INSIDE THE METAL ROTATOR CONNECTOR BROKE AND CAME OFF. THE FLOW RATE WAS 4.3ML/SEC AND THE VOLUME OF THE CONTRAST MEDIUM WAS 35ML. THE PROCEDURE WAS FINISHED SUCCESSFULLY USING A DIFFERENT CATHETER EXTENSION TUBE. THERE WAS NO PATIENT INJURY REPORTED. THE PHYSICIAN COMMENTED THAT HE DID NOT HIT THE UNIT AT THE SITE WHERE IT BROKE TO PURGE AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCS CATH EXTEN 45CM 1200PSI ACCESSORIES DQO CORDIS DE MEXICO NA 15030032

    Patients

    Seq Age Sex Outcome Treatment
    1