BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN PUMP AND CATHETER

    MDR report key: 10450262 · Received August 25, 2020

    Report

    Report Number
    3015537318-2020-00003
    Event Type
    Injury
    Date Received
    August 25, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 25, 2020
    Manufacturer
    INTERA ONCOLOGY
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL AFFAIRS TOOK THE INITIAL PHONE CALL WITH THE PHYSICIAN ON 07/27/2020, IN WHICH HE STATED THAT A NURSE WOULD CALL BACK WITH FURTHER INFORMATION ON THE COMPLAINT. THE INITIAL REPORTER DID NOT CONFIRM THE PUMP MODEL NUMBER OR SERIAL NUMBER. CLINICAL AFFAIRS LEFT A VOICEMAIL ON THE INITIAL REPORTER CELL PHONE ON 07/29/2020. PHYSICIAN CALLED BACK ON 08/03/2020 TO STATE HE WAS GOING TO REPAIR THE CATHETER AS THE PATIENT WAS HAVING INCREASED PAIN. HE DID NOT PROVIDE FURTHER DETAILS AS TO THE PUMP MODEL NUMBER OR SERIAL NUMBER. TO OBTAIN MORE INFORMATION AFTER THE SCHEDULED CATHETER REVISION, CLINICAL AFFAIRS CALLED 08/10/2020; CALL SENT TO VOICEMAIL WITH NO RESPONSE FROM THE PHYSICIAN. QUALITY MANAGER CALLED THE PHYSICIAN'S OFFICE ON 08/12/2020 AND WAS UNABLE TO REACH THE OFFICE ADMINISTRATOR. SHE LEFT A VOICEMAIL ASKING FOR THE MESSAGE TO BE RELAYED TO THE PHYSICIAN. SINCE NO VERBAL CONFIRMATION OF FURTHER DETAILS OF THE INCIDENT AND SUBSEQUENT EXPECTED CATHETER REVISION COULD BE ESTABLISHED, A LETTER ASKING FOR FURTHER INFORMATION WAS SENT VIA FED EX OVERNIGHT WITH SIGNATURE REQUIRED TO THE PHYSICIAN OFFICE ON 08/13/2020. SEE ATTACHMENT FOR LETTER CONTENTS AND PROOF OF DELIVERY. NO FURTHER INFORMATION WAS RECEIVED FROM THE REPORTER DESPITE MULTIPLE ATTEMPTS TO OBTAIN MORE INFORMATION. IT IS UNKNOWN IF THE SCHEDULED CATHETER REVISION TOOK PLACE OR IF THERE IS FURTHER CONFIRMATION FROM THE INITIAL REPORTER OF THE ROOT CAUSE OF THE INCIDENT. THIS MDR IS BEING MADE OFF OF THE BASIS OF KNOWN INFORMATION DESPITE BEING UNABLE TO OBTAIN THE FULL DETAILS OF THE ADVERSE EVENT. IF FURTHER INFORMATION FROM THE INITIAL REPORTER IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    PHYSICIAN BELIEVES THERE IS LEAKAGE OF THE PUMP CONTENTS AT THE PUMP CATHETER NEAR THE INSERTION INTO THE PUMP. WHEN HE ASPIRATED FROM THE CATHETER USING THE SPECIAL BOLUS NEEDLE (SBN) HE WAS ONLY ABLE TO ASPIRATE 0.2 ML APPROXIMATELY. WHEN HE INJECTED DYE USING THE SPECIAL BOLUS NEEDLE, THERE WAS EXTRAVASATION OF THE DYE WHICH POOLED UNDER THE PUMP AND AT THE CATHETER TIP SITE INTRATHECALLY. THERE WAS A PLANNED CATHETER REVISION PLANNED FOR FRIDAY (B)(6) 2020 WHERE HE WILL ATTEMPT TO REPAIR THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915696 CODMAN PUMP AND CATHETER INFUSION PUMP LKK INTERA ONCOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention