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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-17702-E
Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 02/23/2024
Event Type  malfunction  
Event Description
It was reported "swg difficult to advance in patient, and kinking when took out." the user changed to a new set.No medical intevention required.No patient harm or injury.The patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "swg difficult to advance in patient, and kinking when took out." the user changed to a new set.No medical intevention required.No patient harm or injury.The patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a kinked guide wire was able to be confirmed by one photo.The second photo additionally shows the proximal end of the arrow raulerson syringe (ars) along with the kinked guide wire.However, without the sample returned for analysis, a complete visual inspection could not be performed, and the probable root cause could not be confirmed.A device history record review was performed , and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "place tip of arrow advancer - with "j" retracted - into the hole in rear of arrow raulerson syringe plunger or introducer needle.Advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle.Advancement of guidewire through arrow raulerson syringe may require a gentle twisting motion." the ifu also states, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photos.The images show a guidewire in use with a kink observed towards the distal end of the body , however, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key19014458
MDR Text Key339050420
Report Number3006425876-2024-00327
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801902104960
UDI-Public00801902104960
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCS-17702-E
Device Lot Number71F22F1806
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received04/01/2024
Supplement Dates Manufacturer Received04/30/2024
Supplement Dates FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
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