BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW MULTI-LUMEN/PSI KIT 9 FR X 4-1/2" (11.5

    MDR report key: 14058257 · Received April 8, 2022

    Report

    Report Number
    9680794-2022-00222
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    January 25, 2022
    Report Date
    March 17, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902118407
    PMA / PMN Number
    K011761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE MDR REPORT KEY IS (B)(4). THE MDR TEXT KEY IS (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE MDR REPORT KEY IS (B)(4). THE MDR TEXT KEY IS (B)(4).284980160. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "PATIENT WITH A PRE-OPERATIVE DIAGNOSIS INCLUDING SEVERE AORTIC STENOSIS, PRIOR LIVER TRANSPLANT AND FEMORAL-FEMORAL BYPASS WAS ADMITTED TO THE OPERATING ROOM FOR PLACEMENT OF A CENTRAL LINE (ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS). SURGEON FELT GUIDEWIRE RESISTANCE AND HAD TO MANIPULATE THE WIRE TO GET IT OUT. UPON INSPECTION OF THE GUIDEWIRE, DOCTOR SUSPECTED A PIECE BROKE OFF INSIDE THE PATIENT. DOCTOR PLACED A NEW LINE AND CLINICAL STAFF CONTINUED WITH THE PLANNED PROCEDURE. AFTER THE PROCEDURE WAS FINISHED, CLINICAL STAFF LOOKED WITH ULTRASOUND AND X-RAY AND DETERMINED A PART OF THE WIRE WAS RETAINED INSIDE THE PATIENT. DOCTORS SCRUBBED IN TO SEARCH FOR THE PART OF THE WIRE. THE SURGERY WAS PROLONGED ABOUT 3 HOURS. THE PIECE WAS FOUND, TAKEN OUT AND SENT TO PATHOLOGY."

    Description of Event or Problem · 0

    COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "PATIENT WITH A PRE-OPERATIVE DIAGNOSIS INCLUDING SEVERE AORTIC STENOSIS, PRIOR LIVER TRANSPLANT AND FEMORAL-FEMORAL BYPASS WAS ADMITTED TO THE OPERATING ROOM FOR PLACEMENT OF A CENTRAL LINE (ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS). SURGEON FELT GUIDEWIRE RESISTANCE AND HAD TO MANIPULATE THE WIRE TO GET IT OUT. UPON INSPECTION OF THE GUIDEWIRE, DOCTOR SUSPECTED A PIECE BROKE OFF INSIDE THE PATIENT. DOCTOR PLACED A NEW LINE AND CLINICAL STAFF CONTINUED WITH THE PLANNED PROCEDURE. AFTER THE PROCEDURE WAS FINISHED, CLINICAL STAFF LOOKED WITH ULTRASOUND AND X-RAY AND DETERMINED A PART OF THE WIRE WAS RETAINED INSIDE THE PATIENT. DOCTORS SCRUBBED IN TO SEARCH FOR THE PART OF THE WIRE. THE SURGERY WAS PROLONGED ABOUT 3 HOURS. THE PIECE WAS FOUND, TAKEN OUT AND SENT TO PATHOLOGY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156184 ARROW MULTI-LUMEN/PSI KIT 9 FR X 4-1/2" (11.5 CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC IPN037022 13F21G0099 10801902118407

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention N/A.| N/A.