BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRI PORT W/10 FR O-E CATH

    MDR report key: 94226 · Received May 28, 1997

    Report

    Report Number
    1720496-1997-00318
    Event Type
    Injury
    Date Received
    May 28, 1997
    Date of Event
    April 15, 1997
    Report Date
    April 29, 1997
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED PRODUCT IS A PLASTIC DUAL PORT WITH ATTACHABLE OPEN-ENDED 10.0 FR. CATHETER IN A BASIC TRAY. THE PRODUCT RECEIVED FOR EVALUATION IS A PLASTIC DUAL PORT (METAL PORT STEM) WITH A OPEN-ENDED CATHETER ATTACHED. THE COMPLETE ASSEMBLY MEASURES 11.5 LONG. THE CATHETER ITSELF MEASURES 10.4 INCHES. GRADUATED DEPTH MARKERS ARE PRINTED ON THE CATHETER OUTER DIAMETER WITH THE 26 CM DEPTH MARKER AT THE EXTREME PROXIMAL END. VIEWING THE PORT FROM ABOVE WITH THE STEM FACING THE EXAMINER, THE RIGHT SEPTUM IS PARTIALLY DISLODGED, PROTRUDING BETWEEN THE 5 AND 10 O'CLOCK POSITIONS. A DEEP GOUGE IS FOUND IN THE LEFT SEPTUM AT THE 6 O'CLOCK POSITION. THE LOT NUMBER REPORTED BY THE CUSTOMER IS IN ERROR. IT SHOULD BE 36BG3623. A LOT HISTORY REVIEW REVEALS NO RELATED MFG ISSUES AND NO OTHER COMPLAINTS FOR THIS LOT. TEN POWER MAGNIFICATION REVEALS AN INDETERMINATE NUMBER OF NEEDLE PUNCTURE SITES TO BOTH SEPTUMS. NO ASSOCIATED DAMAGE IS OBSERVED TO THE RIGHT (DISLODGED) SEPTUM. PATENCY OF THIS CHAMBER AND THE PROXIMAL CATHETER LUMEN ARE DEMONSTRATED BY OCCLUDING THE DISLODGED SEPTUM WITH FINGER PRESSURE AND FLUSHING AND ASPIRATING WATER WITH A 12CC SYRINGE ARMED WITH A 20 GA. NON-CORING NEEDLE. MICROSCOPIC EXAM SHOWS THE GOUGE IN THE LEFT SEPTUM APPEARS AS A PERPENDICULAR RECTANGLE APPROX. .15 INCHES LONG AND IS ACCOMPANIED BY MANY SUPERFICIAL AND TWO DEEP CYLINDRICAL SCRATCHES IN THE EXTERIOR SURFACE OF THE PORT. THE GOUGE MAY HAVE OCCURRED DURING EXPLANTATION, HOWEVER, THE SCRATCHES ARE SUGGESTIVE OF ACCESS TECHNIQUE DIFFICULTIES. PATENCY OF THE LEFT SEPTUM IS DEMONSTRATED BY FLUSHING AND ASPIRATING WATER USING A 12CC SYRINGE ARMED WITH A 20 GA. NON-CORING NEEDLE. NO LEAKS TO THE LEFT SEPTUM OR CATHETER ARE FOUND WHEN OCCLUDING THE CATHETER'S DISTAL TIP AND HYDRAULICALLY PRESSURIZING THE LUMEN TO SUSTAINED PRESSURES GREATER THAN 25 PSI. TACTUAL EXAM OF THE CATHETER IS UNREMARKABLE. THE COMPLAITN OF A DISLODGED SEPTUM IS CONFIRMED. IT SHOULD BE RECORDED AS USER-RELATED. THE USUAL CAUSE OF SEPTAL DISLODGEMENT IS EXCEEDING DESIGN PRESSURES DURING FLUID ADMINISTRATION. ADDITIONALLY, THE DEVICE CONTAINS EVIDENCE SUGGESTING ACCESS TECHNIQUE DIFFICULTY. THE PRODUCT INSTRUCTIONS FOR USE CAUTIONS AGAINST EXCEEDING 25 PSI DURING INFUSION, AS WELL AS PROVIDES SPECIFIC INSTRUCTIONS FOR ACCESSING PORTS THROUGH TRIANGULATION.

    Description of Event or Problem · 1

    THE PORT BROKE (SEPTUM POPPED OUT). THE PT'S SKIN WAS NOTED TO BE SWOLLEN. THE PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRI PORT W/10 FR O-E CATH INTRAVASCULAR IMPLANTED LJT BARD ACCESS SYSTEMS 0615460 36BG3693

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention