BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY 5F GUIDING CATHETERS

    MDR report key: 4791434 · Received May 22, 2015

    Report

    Report Number
    9616099-2015-00212
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    June 26, 2014
    Report Date
    June 15, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    DQY
    PMA / PMN Number
    K000715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CONTRAST PRODUCT INJECTION, THE BASE OF THE ENVOY CATHETER (55625890/15916460) BROKE. NO CONSEQUENCES TO THE PATIENT BECAUSE THE PROCEDURE WAS FINISHED, IT WAS A CONTROL INJECTION. FAL RECEIVED THE PRODUCT AND THE HUB WAS BROKEN INTO TWO PIECES, BUT THE PIECE THAT SEPARATED WAS NOT RETURNED. A HAND INJECTION WAS UTILIZED, AND VISAPAQUE WAS THE CONTRAST USED. NO DAMAGES NOTICED WITH THE CATHETER (KINKS, BENDS, COMPRESSION, OR OBSTRUCTIONS) DURING INJECTION THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE INTENDED TARGET SITE WAS THE RIGHT VERTEBRAL ARTERIA. ONE NON STERILE UNIT OF VISTA BRITE TIP 5F .056 WAS RECEIVED COILED IN PLASTIC BAG. PER VISUAL ANALYSIS IT WAS NOTICED THE HUB OF UNIT WAS RECEIVED FRACTURED AND SEPARATED IN TWO PIECES, THE SEPARATED PART IS THE HUB THREAD PART AND IT WAS NOT RECEIVED FOR ANALYSIS (SEE ATTACHED PICTURES). SEM ANALYSIS WAS PERFORMED WITH THE FOLLOWING RESULTS: SEM RESULTS SHOWED THAT THE HUB PRESENTED A PATTERN OF DAMAGES THAT COULD BE RELATED TO FORCES APPLIED TO THE FRACTURE ZONE LIKE FLEXION AND FATIGUE. SAMPLE DID NOT PRESENTED EVIDENCE OF DAMAGES INDUCED BY A CHEMICAL SUBSTANCE OR HEAT APPLICATION. NO OTHER EVIDENCES OR ISSUES WERE FOUND DURING SEM ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 15916460 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿LUER HUB- SEPARATED¿ WAS CONFIRMED DURING ANALYSIS, SINCE THE HUB OF THE UNIT WAS RECEIVED FRACTURED AND SEPARATED IN TWO PIECES. ALTHOUGH THE ROOT CAUSE OF THIS FRACTURE WAS NOT CONCLUSIVELY DETERMINED DURING THE ANALYSIS; THIS COMPLAINT UNIT WAS REVIEWED BY THE GUIDING CATHETER PRODUCTION ENGINEERING TEAM (PET) AND IT WAS DETERMINED THAT THIS COMPLAINT IS CONSIDERED AS MANUFACTURING RELATED SINCE THE FRACTURE MAY BE CAUSED DUE TO AN UNBALANCE IN THE MOLDED HUB. MOREOVER, UNIT BELONGS TO LOT # 15894398 MANUFACTURED ON OR BEFORE IMPLEMENTATION OF CORRECTIVE AND PREVENTIVE ACTIONS FOR "GUIDING CATHETER HUB CRACKED". THEREFORE, ADDITIONAL ACTIONS WERE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR REPORTED IN THE SECOND PARAGRAPH OF THE CONCLUSION THAT ¿ONE NON STERILE UNIT OF VISTA BRITE TIP 5F .056 WAS RECEIVED COILED IN PLASTIC BAG.¿ IT SHOULD HAVE STATED ¿ONE NON STERILE UNIT OF GC ENVOY 5F .056 100CM SIM2 WAS RECEIVED COILED IN PLASTIC BAG.¿ THERE WAS NO CHANGE TO THE BASELINE CONCLUSION.

    Additional Manufacturer Narrative · 1

    UNKNOWN GTIN; EXPIRATION DATE = 29-JUN-2013; LOT NUMBER = 15916460; (B)(4). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PRODUCT INVOLVED : ENVOY GC 5F (REF (B)(4)) LOT : 15916460. DURING A CONTRAST PRODUCT INJECTION, THE BASE OF THE ENVOY CATHETER BROKE. HOWEVER, THE PRODUCT WAS RECEIVED AND THE HUB WAS FOUND SEPARATED INTO TWO PIECES. NO CONSEQUENCES TO THE PATIENT BECAUSE THE PROCEDURE WAS FINISHED, IT WAS A CONTROL INJECTION. A HAND INJECTION WAS UTILIZED, AND VISAPAQUE WAS THE CONTRAST USED. NO DAMAGES NOTICED WITH THE CATHETER (KINKS, BENDS, COMPRESSION, OR OBSTRUCTIONS) DURING INJECTION THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE INTENDED TARGET SITE WAS THE RIGHT VERTEBRAL ARTERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334879 ENVOY 5F GUIDING CATHETERS CES GUIDING CATHETERS (DQY) DQY CODMAN AND SHURTLEFF, INC 15916460

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR