BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL PASV PICC

    MDR report key: 892550 · Received August 10, 2007

    Report

    Report Number
    6000126-2007-00085
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FOZ
    PMA / PMN Number
    K981368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THERE HAVE BEEN NO PREVIOUS, SIMILAR COMPLAINTS REPORTED FOR LOT 1192335. THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION CONFIRMED THE REPORTED COMPLAINT CONDITION. A SLIT ON THE OUTSIDE WALL OF THE WHITE VALVE'S LUMEN, THIS FRACTURE WAS BETWEEN THE 4CM AND 5CM MARKS OF THE CATHETER, AND WAS DISTAL TO THE SUTURE WING. THE CATHETER WAS FOUND TO KINK EASILY AT THE SLIT. DURING FUNCTIONAL TESTING OF THE DEVICE, BOTH LUMENS WERE FOUND TO BE PATENT AND ALLOWED AIR TO BE INFUSED THROUGH THEM BY HAND WITH A SYRINGE. THIS WAS EVIDENT WHEN AIR WAS INFUSED IN THE DEVICE WHILE IT WAS SUBMERGED IN WATER, AND BUBBLES WERE VISIBLE COMING OUT OF THE DISTAL END OF THE CATHETER. SIMILAR TESTING CONFIRMED THAT THERE WERE NO LEAKS IN THE CATHETER'S LUMENS, OTHER THAN THE AREA OF THE FAILURE. THE CATHETER WAS CUT AT THE 6 CM DEPTH MARK TO COMPLETE DIMENSIONAL INSPECTION OF THE CATHETER WALL AND SEPTUM NEAR THE AREA OF THE FAILURE. THE SAMPLE WAS MEASURED WITH CALIPERS. ALL DIMENSIONS WERE FOUND TO BE WELL WITHIN TOLERANCE AS DEFINED IN THE SPECIFICATIONS CONTAINED ON THE CATHETER DRAWING. BASED ON THE CONDITION OF THE RETURNED DEVICE, AND THE FACT THAT NO CURRENT ADVERSE TREND HAS BEEN NOTED FOR THIS FAILURE MODE, THIS FAILURE DOES NOT APPEAR TO BE AN ASSEMBLY RELATED DEFECT. DUE TO THE KINK OBSERVED AT THE SPLIT SITE AND THE NATURE OF THE SPLIT IN THE LUMEN WALL, WHICH IS CONSISTENT WITH PREVIOUSLY VIEWED SAMPLES FROM OVER PRESSURIZATION, THE MOST LIKELY ROOT CAUSE MAY BE KINKING AND/OR OVER PRESSURIZING OF THE LUMEN, CAUSING THE CATHETER WALL TO FAIL; ALTHOUGH, THAT CAN NOT BE DEFINITIVELY DETERMINED AT THIS TIME. A REVIEW OF THE JUNE 2007 COMPLAINT REPORT FOR THE VAXCEL PASV PICC-POLY FAMILY DID NOT REVEAL A CURRENT ADVERSE TREND IN THE "FRACTURE DISTAL TO SUTURE WING" OR "HOLE IN CATHETER" FAILURE MODES. IN ADDITION, THE JULY 2007 15 MONTH PICCS VALVED COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURES MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. THE DIRECTIONS FOR USE (DFU) FOR THIS DEVICE ADVISES THE USER OF THE FOLLOWING: IF CATHETER AND COMPONENTS SHOW ANY SIGN OF DAMAGE (CRIMPED, CRUSHED, CUT, ETC.), DO NOT USE. IN ADDITION, THE DFU CAUTIONS THE USER: AVOID SHARP OR ACUTE ANGLES DURING IMPLANTATION WHICH COULD COMPROMISE CATHETER FUNCTIONALITY... EXCESSIVE FORCE SHOULD NOT BE USED TO FLUSH AN OBSTRUCTED LUMEN. DO NOT US A SMALLER SYRINGE THAN 10 ML. REFER TO THE MANAGEMENT OF LUMEN OCCLUSION SECTION OF THIS DOCUMENT AND INSTITUTIONAL PROTOCOL FOR CLEARING OCCLUDED CATHETERS.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A VAXCEL PASV PICC WAS THERAPEUTICALLY PLACED IN THE UPPER RIGHT ARM OF A MALE PATIENT (AGE UNKNOWN) IN 2007. THE IMPLANT PROCEDURE PERFORMED FOR TOTAL PARENTERAL NUTRITION (TPN) WAS SUCCESSFUL. ON THE FOLLOWING MONTH, IT WAS NOTICED THAT THE PATIENT HAD DEVELOPED TPN INFILTRATION, RESULTING IN PATIENT DISCOMFORT. THE PATIENT DEVELOPED REDNESS AND SWELLING AT THE SITE OF THE TPN EXTRAVASATION. THE CLINICIANS THEN CHECKED THE DEVICE AND IDENTIFIED A ONE HALF CENTIMETER SLIT IN THE CATHETER LOCATED FOUR CENTIMETERS DISTAL TO THE SUTURE WING. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT DURING AN OVER THE WIRE EXCHANGE. THE PATIENT WAS TREATED WITH WARM PACKS FOR HIS DISCOMFORT, AND IS NOW REPORTED TO BE FINE WITH NO FURTHER ADVERSE AFFECT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PASV PICC FOZ BOSTON SCIENTIFIC NA 1192335

    Patients

    Seq Age Sex Outcome Treatment
    1 YR