BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFORCE¿ PERIPHERAL CROSSING SET

    MDR report key: 4959056 · Received August 1, 2015

    Report

    Report Number
    1820334-2015-00497
    Event Type
    Malfunction
    Date Received
    August 1, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    COOK INC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). K111263. INVESTIGATION - EVALUATION DURING THE COURSE OF INVESTIGATION, THE KCXS PRODUCT ALONG WITH THE RETURNED CONNECTING TUBE, WAS VISUALLY INSPECTED. A REVIEW OF THE INSTRUCTIONS FOR USE WAS ALSO CONDUCTED. BASED ON CUSTOMER TESTIMONY, "THE PLASTIC SIDE-HUB IS CRACKED." THE VISUAL INSPECTION OF THE RETURNED DEVICE DETERMINED THE HUB OF THE CONNECTING TUBE WAS CRACKED. HOWEVER, THE VISUAL INSPECTION NOTED THAT THE RETURNED CONNECTING TUBE IS NOT A COOK, INC. DEVICE; THEREFORE, THE COMPLAINT WAS NOT CONFIRMED. PER THE DEVICE DESCRIPTION IN THE PROVIDED INSTRUCTIONS FOR USE (IFU); IT IS STATED: "THE SET INCLUDES THREE COMPONENTS: AN OUTER 5.0 FRENCH FLEXOR SHEATH WITH RADIOPAQUE TIP AND HYDROPHILIC COATING, AN INNER 4.0 FRENCH CXI SUPPORT CATHETER, AND A PEEL-AWAY(R) SHEATH." THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO ANOTHER DRUG/DEVICE DUE TO THE COMPLAINT REFERRING TO THE CONNECTING TUBE, WHICH IS NOT MANUFACTURED BY COOK, INC. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PLASTIC SIDE-HUB IS CRACKED. THE PHYSICIAN ELECTED TO USE A DIFFERENT SHEATH TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT THE PLASTIC SIDE-HUB IS CRACKED. THE PHYSICIAN ELECTED TO USE A DIFFERENT SHEATH TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502481 TRIFORCE¿ PERIPHERAL CROSSING SET KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1