BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIAL CATH BAR TYPE E

    MDR report key: 3651329 · Received February 27, 2014

    Report

    Report Number
    1226348-2014-11274
    Event Type
    Injury
    Date Received
    February 27, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, WE RECEIVED AN EMAIL FROM PROF. (B)(6) THAT HE HAD PROBLEMS WITH THE CATHETER 82-1676. HE WROTE THAT HE HAD A CATHETER ABRIDGMENT ON THE RELIVED AREA OF THE CATHETER (WHERE IT GETS THINNER). PATIENT WITH VA SHUNT. (B)(6) ADDITIONAL INFORMATION. PATIENT FEMALE BORN 2005 IMPLANTATION (B)(6) 2013, PRODUCT 821676, HOLTER ATRIAL CATHETER, TYP E LOT: CNHC69, THEY USE A 4,5 PTFE PEELAPART, PERCUTANEOUS.,INTRODUCER KIT LOT: REUE0309 FORM THE COMPANY BARD EXPLANTATION: (B)(6) 2014, (HEART REMOVING CATHETER ABRIDGEMENT PART- INTERVENTION). DESCRIPTION: ABRIDGEMENT OF THE CERVICAL/CRANIAL END OF THE CATHETER WITH DISLOCATION TO CARDIAL. PLEASE NOTE ON STOCK THEY HAVE 4 ORIGINAL PACKAGE 3X LOT CPDDJG AND 1X LOT CNBCM6 . SHOULD WE SENT THIS BACK TO (B)(4) FOR INVESTIGATION? WE DIDN¿T GET THE REMOVED CATHETER PART FROM THE HOSPITAL BUT WE RECEIVED SEVERAL PICTURES. AGAINST THIS BACKGROUND WE WOULD ACCESS THIS COMPLAINT AS MDV REPORTABLE. BEST REGARDS, (B)(4). (B)(6) AS WE RECEIVED FURTHER INFORMATION WE CHANGED THE DECISION TO MDV REPORTABLE ON MONDAY. THE RELIVED AREA ON THE CATHETER MEANS, THE PART WHERE THE CATHETER GETS THINNER,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120095 ATRIAL CATH BAR TYPE E SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CNHC69

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention