BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAXCEL WITH PASV PICC (PERIPHERALLY INSERTED CENTRAL CATHETE

    MDR report key: 467098 · Received June 16, 2003

    Report

    Report Number
    MW1028733
    Event Type
    Other
    Date Received
    June 16, 2003
    Date of Event
    May 30, 2003
    Report Date
    June 5, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FKO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/10/03: ALL OF THE REPORTED EXPERIENCES DESCRIBE A BREAK IN THE EXTENSION TUBE (OR A HOLE) THAT DEVELOPED DURING USE. THERE WERE NO PT INJURIES. NONE OF THE INCIDENTS WERE REPORTED TO BSC BY THE CUSTOMER. MFR ENTERED THE INCIDENTS INTO ITS COMPLAINT SYSTEM AND INITIATED FOLLOW-UP TO OBTAIN A DETAILED DESCRIPTION. RPTR STATED THAT ALL OF THE SAMPLE PRODUCTS INVOLVED HAD BEEN DISCARDED. THEY HAD NO ADD'L INFO ABOUT THE INCIDENTS, EXCEPT THAT THE TUBING FRACTURED AT THE JUNCTION OF THE EXTENSION PART OF THE CATHETER AND THE HUB. NO SAMPLE WAS RETURNED FOR METHODOLOGIES TO BE APPLIED. NO SAMPLE WAS RETURNED FOR IDENTIFICATION/CONFIRMATION OF THE FAILURE MODE(S). NO CONCLUSIONS COULD BE MADE, SINCE NO SAMPLES WERE RETURNED. ALTHOUGH BOSTON SCIENTIFIC CORP DID NOT RECEIVE A PRODUCT SAMPLE FROM THE FACILITY FOR THESE SPECIFIC MEDWATCH REPORTS, IT HAS COMPLAINTS ON FILE FOR SIMILAR EXPERIENCES WITH THIS DEVICE. CO'S INVESTIGATIONS INTO THESE COMPLAINTS HAD ALREADY INDICATED THAT INAPPROPRIATE USE OF ALCOHOL OR ACETONE CAN RESULT IN THIS TYPE OF FAILURE. CO INSTITUTED INSERVICE TRAINING AMONG CUSTOMERS, INCLUDING THIS CUSTOMER TO REINFORCE THE PROPER HANDLING AND CARE PER THE DFU. THE DFU CONTAINS A PRECAUTION STATING "CARE SHOULD BE TAKEN WHEN USING ALCOHOL OR ACETONE. ALLOW FOR COMPLETE DRYING OF ALCOHOL OR ACETONE DURING ROUTINE CARE AND MAINTENANCE". NONE OF THE DEVICES INVOLVED IN THESE INCIDENTS WERE RETURNED TO BOSTON SCIENTIFIC. THE DEVICE WAS DESTROYED/DISCARDED BY THE CUSTOMER. ALTHOUGH THERE WAS NO CUSTOMER COMPLAINT SUBMITTED OR PRODUCT RETURNED FOR THESE MEDWATCH REPORTS, THIS CUSTOMER HAD RETURNED PRODUCT PREVIOUSLY AND THE INFO GAINED FROM EVALUATION OF THAT PRODUCT WAS USED IN THIS RESPONSE. DURING CO'S INVESTIGATIONS, IT CONFIRMED THE CATHETER EXTENSION TUBE'S SUSCEPTIBILITY TO KINKING AND FLEXING IN COMBINATION WITH ALCOHOL CONTACT. IN ADDITION, CO DISCOVERED THAT THE EXTENSION TUBE'S RESISTANCE TO KINKING AND ALCOHOL COULD BE MADE MORE ROBUST WITH A MINOR PROCESSING CHANGE. THE EXTENSION TUBES ARE THEN PROCESSED THROUGH THE ORIGINAL CATHETER ASSEMBLY PROCESS. THIS CHANGE WAS APPROVED AND IMPLEMENTED IN JUNE 2003.

    Description of Event or Problem · 1

    RN WAS TRYING TO DISCONNECT THE CAP FROM THE HUB BUT HAD DIFFICULTY SO SHE WAS TWISTING THE HUB PART AND BROKE THE JUNCTION OF THE HUB AND EXTERNAL PART OF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL WITH PASV PICC (PERIPHERALLY INSERTED CENTRAL CATHETE VASCULAR ACCESS DEVICE FKO BOSTON SCIENTIFIC CORPORATION * 4010203229

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other