BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW CLAMP CATHETER COMPONENT

    MDR report key: 6837989 · Received September 1, 2017

    Report

    Report Number
    3006425876-2017-00336
    Event Type
    Death
    Date Received
    September 1, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 10, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    PUK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 017-00313, (B)(4). THE DEVICE IS NOT INTENDED FOR SALE IN THE US. SIMILAR DEVICE SOLD IN THE US. ACCORDING TO THE CORRESPONDENCE RECEIVED FROM THE USER FACILITY, THE CVC WAS SUTURED ONLY AT THE CLAMP/FASTENER AND NOT AT THE HUB. THIS IS CONTRARY TO THE PRODUCT INSTRUCTIONS FOR USE, WHICH REQUIRES SUTURING AT THE JUNCTION HUB AS THE PRIMARY SUTURE SITE, WITH THE CLAMP/FASTENER AS THE SECONDARY SUTURE SITE. A COMPANION REPORT (MDR# 3006425876-2017-00313) FOR THE SAME INCIDENT HAS BEEN FILED FOR THE CVC SET NOTED IN CONCOMITANT MEDICAL PRODUCTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORTED COMPLAINT THAT CATHETER MIGRATED COULD NOT BE CONFIRMED AS A SAMPLE WAS NOT PROVIDED FOR EVALUATION. ALTHOUGH A SAMPLE WAS NOT PROVIDED FOR THIS COMPLAINT, THE CUSTOMER CONFIRMED THAT THE CVC WAS NOT FIXED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS SUTURED AND SECURED USING ONLY THE BOX CLAMP, INSTEAD OF USING THE TRIANGULAR JUNCTURE HUB AS THE PRIMARY SUTURE SITE AND THE BOX CLAMP AS A SECONDARY SUTURE SITE AS NECESSARY. BASED ON THE INFORMATION RECEIVED, THE PRIMARY CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT. TELEFLEX HAS SENT THE CUSTOMER A LETTER THAT EXPLAINS "HOW TO SECURE THE CATHETER".

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE CATHETER SHOVED OUT OF THE FASTENER. THE CUSTOMER REPORTS THAT THEY ONLY PUT A SUTURE ON THE CLAMP AND NO SUTURE ON THE HUB OF THE PRIMARY CATHETER ITSELF. THE CATHETER USED BY THE USER FACILITY IS FOR CATALOG# EU-15703-CVT CVC SET AND IS DOCUMENTED IN MDR# 3006425876-2017-00313. DURING SHIFTING OF THE PATIENT, IT WAS NOTED THAT THE LINE HAD SLIPPED OUT, CAUSING AN INTERRUPTION IN THE ADMINISTRATION OF INOTROPIC MEDICATION. A NEW CATHETER WAS PLACED (FEMORAL PLACEMENT). AFTER DISLOCATION OF THE INITIAL CVC, THE PATIENT'S BLOOD PRESSURE DECREASED SUCH THAT THE PATIENT NEEDED RESUSCITATION. DURING RESUSCITATION A BLEED OCCURRED. THE THORAX WAS RE-OPENED. THE PATIENT CLINICALLY WORSENED AND DIED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE CATHETER SHOVED OUT OF THE FASTENER. THE CUSTOMER REPORTS THAT THEY ONLY PUT A SUTURE ON THE CLAMP AND NO SUTURE ON THE HUB OF THE PRIMARY CATHETER ITSELF. THE CATHETER USED BY THE USER FACILITY IS FOR CATALOG# EU-15703-CVT CVC SET AND IS DOCUMENTED IN MDR# 3006425876-2017-00313. DURING SHIFTING OF THE PATIENT, IT WAS NOTED THAT THE LINE HAD SLIPPED OUT, CAUSING AN INTERRUPTION IN THE ADMINISTRATION OF INOTROPIC MEDICATION. A NEW CATHETER WAS PLACED (FEMORAL PLACEMENT). AFTER DISLOCATION OF THE INITIAL CVC, THE PATIENT'S BLOOD PRESSURE DECREASED SUCH THAT THE PATIENT NEEDED RESUSCITATION. DURING RESUSCITATION A BLEED OCCURRED. THE THORAX WAS RE-OPENED. THE PATIENT CLINICALLY WORSENED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617328 ARROW CLAMP CATHETER COMPONENT IV SECUREMENT DEVICE PUK ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CVC SET (CATALOG# EU-15703-CVT)(B)(4)