BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

    MDR report key: 5350550 · Received January 7, 2016

    Report

    Report Number
    1820334-2016-00003
    Event Type
    Injury
    Date Received
    January 7, 2016
    Date of Event
    December 18, 2015
    Report Date
    December 21, 2015
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). K150733 INVESTIGATION- A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL (QC) AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. THE INTRODUCER FROM AN IP-S7010 DEVICE WAS RETURNED WITH THIS COMPLAINT. VISUAL INSPECTION CONFIRMED THAT A SMALL FRAGMENT OF THE DISTAL END OF THE PEEL-AWAY SHEATH WAS DETACHED FROM THE DEVICE. THE FRAGMENT WAS OBSERVED UNDER MAGNIFICATION. IT APPEARS THAT THIS FRAGMENT SUSTAINED DAMAGE THAT CAUSED IT TO BUNCH PROXIMAL TO THE FORCE APPLIED. THE SITE OF FRACTURE ON BOTH THE FRAGMENT AND THE OUTER SHEATH WAS OBSERVED UNDER MAGNIFICATION. IT APPEARS THAT THE SHEATH WAS SHEARED BECAUSE THE BREAK IS IN A STRAIGHT LINE. NO SIGNS OF TORSION, TEARING, OR STRAIN ON THE SHEATH WERE OBSERVED. NO DAMAGE WAS OBSERVED TO THE DILATOR. THOUGH INTERVENTION WAS PERFORMED TO RETRIEVE THE PORTION OF THE DEVICE, THERE IS NO EVIDENCE THAT THE PATIENT WAS HARMED DUE TO THIS EVENT. MANUFACTURING RECORDS FOR THIS DEVICE WERE REVIEWED, AND ALL STEPS WERE PERFORMED AND DOCUMENTED BY TRAINED PERSONNEL. QC RECORDS FOR THE COMPONENT WERE REVIEWED, AND ALL STEPS WERE PERFORMED AND DOCUMENTED BY TRAINED PERSONNEL. THERE IS NO EVIDENCE THAT A NONCONFORMITY WAS PRESENT IN THIS DEVICE. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS DEVICE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). K150733. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHILE INSERTING A PEELAWAY SHEATH, THE TOP OF SHEATH SNAPPED IN THE PATIENT. THE SHEATH WAS ABLE TO BE RETRIEVED FROM THE PATIENT. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE..

    Description of Event or Problem · 1

    DURING THE PROCEDURE, WHILE INSERTING A PEELAWAY SHEATH, THE TOP OF SHEATH SNAPPED IN THE PATIENT. THE SHEATH WAS ABLE TO BE RETRIEVED FROM THE PATIENT. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11600 VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER LJT COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention