BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM

    MDR report key: 8975230 · Received September 9, 2019

    Report

    Report Number
    1036844-2019-00944
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 26, 2019
    Report Date
    August 27, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K011761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE DILATOR AND A LIDSTOCK FOR ANALYSIS. NO OBVIOUS SIGNS-OF-USE WERE OBSERVED ON THE DILATOR. VISUAL ANALYSIS OF THE DILATOR REVEALED THAT THE DILATOR TIP WAS TORN BACK ON THE SIDE. ADDITIONALLY, THE DILATOR TIP WAS ALSO SPLIT AROUND THE CIRCUMFERENCE. MICROSCOPIC EXAMINATION OF THE TORN SIDE REVEALED WHITE DISCOLORATION, INDICATING STRESS. THE DILATOR LENGTH FROM THE HUB TO THE DISTAL TIP MEASURED 8 13/16", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 8 3/4"-8 7/8" PER THE DILATOR GRAPHIC. THE DILATOR OUTER DIAMETER MEASURED .1178", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .117"-.120" PER THE DILATOR GRAPHIC. THE DILATOR INNER DIAMETER MEASURED .053", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .048"-.058" PER THE DILATOR GRAPHIC. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED CAUSE. THE IFU PROVIDED WITH THE KIT INFORMS THE USER "ENLARGE CUTANEOUS PUNCTURE SITE WITH CUTTING EDGE OF SCALPEL POSITIONED AWAY FROM THE SPRING-WIRE GUIDE" PRIOR TO DILATOR INSERTION. THE IFU ALSO CAUTIONS, "ALCOHOL AND ACETONE CAN WEAKEN THE STRUCTURE OF POLYURETHANE MATERIALS. CHECK INGREDIENTS OF PREP SPRAYS AND SWABS FOR ACETONE AND ALCOHOL CONTENT. ACETONE: DO NOT USE ACETONE ON ACCESS DEVICE SURFACE. ACETONE MAY BE APPLIED TO SKIN BUT MUST BE ALLOWED TO DRY COMPLETELY PRIOR TO APPLYING DRESSING." THE REPORTED COMPLAINT OF THE DILATOR TIP DAMAGED DURING USE WAS CONFIRMED BY COMPLAINT INVESTIGATION. THE RETURNED DILATOR WAS CRACKED/TORN, AND THE MATERIAL WAS FOLDED BACK. THE DILATOR TIP CONTAINED DISCOLORATION AT THE CRACKS, INDICATING STRESS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED ISSUE. BASED ON THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE DILATOR WAS SHARP AND ALREADY CRIMPED AT THE TIP PRIOR USING IT ON THE PATIENT. THEY REMOVED IT FROM THE PATIENT AND OBTAINED A NEW ONE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE DILATOR WAS SHARP AND ALREADY CRIMPED AT THE TIP PRIOR USING IT ON THE PATIENT. THEY REMOVED IT FROM THE PATIENT AND OBTAINED A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767672 ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. 23F19F0324

    Patients

    Seq Age Sex Outcome Treatment
    1