BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 7008008 · Received November 7, 2017

    Report

    Report Number
    1820334-2017-03672
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Report Date
    January 11, 2018
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002355507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K133114. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONLY THE OUTER SHEATH AND HUB FROM ONE USED MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET. THE OUTER SHEATH AND HUB WERE SEPARATED. NO BLOCKAGE IS NOTED IN THE HUB. THE PROXIMAL END IS COMPRESSED 8 MM IN LENGTH. ACCORDION DAMAGE STARTS AT 8 MM FROM THE PROXIMAL END TO 14 MM. TWO SPLITS ON THE DISTAL TIP ARE NOTED, EACH MEASURES 0.5 MM IN LENGTH. THE DEVICE MET DIAMETER REQUIREMENTS. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS LOT NUMBER. THE INTRODUCERS BROKE AS THE DOCTOR WAS REMOVING THE DEVICE FROM THE PATIENT. NO PATIENT PRE-EXISTING CONDITIONS AND OR ANATOMIC CONSIDERATIONS RELATIVE TO THE CASE WERE AVAILABLE. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET INTRODUCER SHEATH FRACTURED AT THE SITE WHERE THE SHEATH MEETS THE HUB. THE INTRODUCER SHEATH BROKE AS THE PHYSICIAN WAS REMOVING IT FROM THE PATIENT. NO INTERVENTION WAS REQUIRED AS A RESULT. TWO MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SETS WERE UTILIZED DURING PROCEDURES, AND ONE WAS REPORTED TO BE UNOPENED/ UNUSED. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784917 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC 00827002355507

    Patients

    Seq Age Sex Outcome Treatment
    1