BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 5F INFINITI TL PIG145 110

    MDR report key: 3905393 · Received July 1, 2014

    Report

    Report Number
    9616099-2014-00439
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 11, 2011
    Report Date
    June 12, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S GENDER IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    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. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HOSPITAL STAFF CONSIDERS MATTER CLOSED. THE ANGULATED PIGTAIL WAS FLUSHED AND SUBSEQUENTLY PLACED ON A 150 .38 J WIRE. THIS CATHETER WAS NEVER PLACED INTO THE PATIENT. WE FOUND IT IN TWO PARTS ONCE IT WAS FED ONTO THE J-WIRE AND THEN REMOVED IT. THE PIGTAIL WAS IN TWO PHYSICAL SEPARATE PIECES; THE CURVED END WAS SEPARATED FROM THE REST OF THE CATHETER. AN INTERVENTIONAL FELLOW WAS PERFORMING THE PROCEDURE. THE INTENDED PROCEDURE WAS A SCA WITH A RADIAL PUNCTURE. DEVICE WAS USED FOR DIAGNOSIS. NO INJECTION OF CONTRAST OCCURRED AS THIS CATHETER WAS NEVER PLACED INTO THE PATIENT. THE DEVICE WAS NOT REPROCESSED. WHEN THE CATHETER BROKE, THE PIGTAIL WAS REMOVED FROM THE J-WIRE AND BAGGED. A NEW CORDIS PIGTAIL CATHETER WAS USED AFTER VERIFYING ITS INTEGRITY. THE VESSEL WAS NEITHER CALCIFIED NOR TORTUOUS; HOWEVER, THE FAULTY PIGTAIL WAS NEVER PLACED INTO THE PATIENT. THE STAFF HAS RESPECTFULLY DECLINING ANY FURTHER FOLLOW UP. THE PRODUCT WAS NOT INVOLVED IN A CLINICAL TRIAL. THE COMPONENT WILL BE RETURNED. NO PATIENT INFORMATION WILL BE PROVIDED. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A DIAGNOSTIC PROCEDURE PERFORMED BY AN INTERVENTIONAL FELLOW, THE PROXIMAL END OF THE SHAFT OF AN INFINITI PRODUCT SEPARATED 20MM FROM THE HUB PRIOR TO PATIENT USE. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. THE INTENDED PROCEDURE WAS A SCA WITH A RADIAL PUNCTURE; THE VESSEL WAS NEITHER CALCIFIED NOR TORTUOUS. THE ANGULATED PIGTAIL WAS FLUSHED AND SUBSEQUENTLY PLACED ON A 150 .38 J WIRE BUT NEVER INSERTED INTO THE PATIENT. ¿WE FOUND IT IN TWO PARTS ONCE IT WAS FED ONTO THE J-WIRE AND THEN REMOVED IT.¿ THE PIGTAIL WAS IN TWO PHYSICAL SEPARATE PIECES; THE CURVED END WAS SEPARATED FROM THE REST OF THE CATHETER. THE INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS ¿SPOTLESS CLEAN (NO BLOOD), WHICH INDICATED THAT THE DEVICE SEPARATED WHEN BEING IMPROPERLY PULLED FROM PACKAGE PRIOR TO CASE.¿ WHEN THE CATHETER BROKE, THE PIGTAIL WAS REMOVED FROM THE J-WIRE AND PACKAGED FOR PRODUCT RETURN. A NEW CORDIS PIGTAIL CATHETER WAS USED AFTER VERIFYING ITS INTEGRITY. THE DEVICE WAS NOT REPROCESSED. NO PICTURES ARE AVAILABLE. THE COMPONENT WILL BE RETURNED. THE HOSPITAL NO LONGER WISHES TO PURSUE THIS ANY FURTHER AND DECLINED FURTHER FOLLOW UP; THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE. A NON STERILE DIAGNOSTIC CATH F5 INF PIG145 110CM 6SH WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS THE BODY SHAFT OF CATHETER WAS RECEIVED SEPARATED IN TWO PIECES. HUB WAS FOUND SEPARATED FROM BODY SHAFT OF CATHETER. UNIT¿S SEPARATED PIECES WERE INSPECTED UNDER VISION SYSTEM. THE SEPARATED EDGES ON THE RECEIVED PROXIMAL END OF CATHETER BODY SHAFT LOOKS AS IF TREMENDOUS FORCE WAS APPLIED UNTIL BREAK/SEPARATION OCCURS ON UNIT. NO OTHER ANOMALIES WERE FOUND. THE CATHETER BODY SHAFT PROXIMAL END OD AND ID WERE MEASURED NEAR TO THE SEPARATION CONDITION AND RESULTS WERE FOUND WITHIN SPECIFICATION. THE RECEIVED HUB WAS X-RAYED AND CROSS-SECTIONED IN ORDER TO INSPECT THE MOLDED CONDITION OF THE STRAIN RELIEF AND BODY SHAFT PROXIMAL END. REMNANTS OF BODY SHAFT IN THE WALLS OF LUER HUB WERE OBSERVED. SEM ANALYSIS WAS PERFORMED TO THE RECEIVED CATHETER BODY SHAFT SEPARATED PROXIMAL END WITH THE FOLLOWING RESULTS: SEM RESULTS SHOW THAT THE BODY EXTERNAL SURFACE PRESENTED EVIDENCE OF ELONGATION AT THE SURROUNDINGS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS. ACCORDING TO X-RAY, SEM AND CROSS-SECTION IMAGES/RESULTS OBTAINED IT IS CONCLUDED THAT THE CATHETER BODY SHAFT WAS PROPERLY PLACED TO BE MOLDED INTO THE HUB. THE INTERNAL SECTION OF THE HUB SHOWED EVIDENCE OF A REMNANT OF BODY INSIDE OF THE HUB PER X-RAY PICTURES. AT CROSS SECTION PICTURES THE REMNANT OF BODY WAS CONFIRMED. AT SEM IT WAS OBSERVED ELONGATION ON THE BODY. ELONGATION IS A COMMON CHARACTERISTIC OF SAMPLES WHICH WERE PULLED OR OVER STRETCHED. FUNCTIONAL ANALYSIS TO PERFORM PULL TEST WAS NOT CONDUCTED DUE TO NO STERILE UNITS RETURNED FOR ANALYSIS. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿DIAGNOSTIC CARDIOLOGY CATHETER-CATHETER (BODY/SHAFT)- SEPARATED¿ WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. HOWEVER, THE EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE, HANDING FACTORS DURING REMOVAL OF THE DEVICE FROM THE PACKAGE AND/OR DURING PREPARATION MAY HAVE CONTRIBUTED TO SEPARATION AS EVIDENCED BY ELONGATION/ STRETCHING NOTED AT THE POINT OF SEPARATION. NEITHER THE DRH NOR ANALYSIS SUGGEST THAT THE SEPARATION IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED BY A QUAL REP, THE PROXIMAL END OF THE SHAFT OF AN INFINITI PRODUCT SEPARATED 20MM FROM THE HUB PRIOR TO PATIENT USE. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. PER THE QUAL REP, THE DEVICE WAS SPOTLESS CLEAN (NO BLOOD), WHICH INDICATED THAT THE DEVICE SEPARATED WHEN BEING IMPROPERLY PULLED FROM PACKAGE PRIOR TO CASE. NO PICTURES ARE AVAILABLE. THE HOSPITAL NO LONGER WISHES TO PURSUE THIS ANY FURTHER, THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383037 CATH 5F INFINITI TL PIG145 110 DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 16086502

    Patients

    Seq Age Sex Outcome Treatment
    1