BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL PASV PICC

    MDR report key: 982046 · Received January 22, 2008

    Report

    Report Number
    3005099803-2008-00070
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    October 17, 2007
    Report Date
    December 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJS
    PMA / PMN Number
    K021704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THIS LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED ONE OTHER COMPLAINT FOR LOT NUMBER 1201454. THAT COMPLAINT WAS RECEIVED FROM THE SAME HOSPITAL, ON THE SAME DAY AND FOR A SIMILAR COMPLAINT ISSUE. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION OF THE DEVICE, EVIDENCE OF HYDRATION WAS NOTED INSIDE THE DEVICE'S PROTECTIVE LOOP. THE INSPECTION ALSO CONFIRMED THAT THE DISTAL TIP OF THE GUIDEWIRE HAD BEEN UNRAVELED, RATHER THAN STRETCHED. THE DEVICE WAS THEN FORWARDED TO THE OEM SUPPLIER OF THE GUIDEWIRE FOR EVAL. THE SUPPLIER ANALYSIS OF THE DEVICE INCLUDED A VISUAL EXAMINATION WITH IMAGE CAPTURE OF THE SPECIMEN AND DIMENSIONAL VERIFICATION. THE EVAL CONFIRMED THAT THE RETURNED GUIDEWIRE EXHIBITED NUMEROUS KINKS AND BENDS, THIS APPEARED CONSISTENT WITH THE PREVIOUSLY VIEWED SAMPLES OF FAILED ATTEMPTS TO ADVANCE AND OR RETRACT SPECIMENS AGAINST A CONSTRAINT OR OBSTRUCTION. THE PROXIMAL END OF THE WIRE IS A WIRE SHAFT; THE DISTAL TIP REGION CONTAINS THE FLEXIBLE COIL SEGMENT. THE DISTAL TIP APPEARS THAT IT MAY HAVE CAUGHT ON THE SHOULDER OF THE LUER HUB ATTACHED TO THE DISPENSER ASSEMBLY AND BECOME DAMAGED, AS IT WAS PROLAPSED OVER THE OBSTRUCTION. THE SUPPLIER ALSO FOUND THAT THERE WAS APPARENT BIOMATERIAL RESIDUE PRESENT OVER THE LENGTH OF THE SPECIMEN. THE GREATEST CONCENTRATIONS OF BIOMATERIAL WERE FOUND TO BE LOCATED OVER THE DISTAL COIL TO THE CORE WIRE JOINT REGION OF THE WIRE, WHICH IS AN INDICATION OF CLINICAL USE. AT THIS TIME, IT APPEARS THAT THESE FACTORS MAY HAVE IMPACTED ON THE EVENT AS REPORTED. THE ROOT CAUSE FOR THE REPORTED PROBLEM HAS BEEN UNABLE TO BE DEFINITELY DETERMINED. THERE WERE NO VISIBLE MFG DEFECTS IN THE RETURNED SAMPLE. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS MEDWATCH REPORT WAS INITIATED UPON THE PHYSICAL EVAL OF THE RETURNED DEVICE, AT WHICH TIME IT WAS DETERMINED THAT THE DEVICE EXHIBITED A REPORTABLE CONDITION. THE COMPLAINANT REPORTED THAT DURING THE PREPARATION FOR THERAPEUTIC IMPLANT OF A VAXCEL PASV PICC IN A FEMALE PT (AGE AND WEIGHT UNK), THE CLINICIAN FOUND THAT THE GUIDEWIRE'S PROXIMAL TIP WAS FUSED TO THE INTRODUCER INSIDE THE PROTECTIVE CARRIER HOOP. AS A RESULT, WHEN THE CLINICIAN TRIED TO REMOVE THE GUIDEWIRE FROM THE HOOP, IT BECAME STRETCHED. THE PHYSICIAN REPORTED, THAT THE PT PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. IT WAS ALSO REPORTED THAT THERE WERE NO PT COMPLICATIONS AND THAT THE PT WAS FINE. DURING DEVICE EVAL OF THE GUIDEWIRE THAT WAS RETURNED FROM THE COMPLAINANT FACILITY, THE INVESTIGATORS NOTED THAT HE TIP OF THE GUIDEWIRE HAD UNRAVELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PASV PICC LJS BOSTON SCIENTIFIC M001454730 1201454

    Patients

    Seq Age Sex Outcome Treatment
    1