MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER SUBCLAVIAN

Catalog Number	CS-15122-F
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the resistance when the swg inserted into the ars during use on the same patient.The swg was found kinked when withdrawing the swg.They changed a new one to resolve the issue." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, opened hemodialysis kit containing a guide wire assembly.Per the report from the customer, this returned sample is representative.It was noted that an arrow raulerson syringe (ars) was not returned.Visual analysis did not reveal any defects or anomalies on the returned guide wire.Visual analysis could not be performed on the actual guide wire or the ars as they were not returned for analysis.The guide wire length measured 684mm, which is within the specification limits of 678mm-688mm per the guide wire product drawing.The guide wire outer diameter measured 0.85mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The returned guide wire was inserted through a lab inventory ars/18 ga introducer needle.No resistance was encountered as the guide wire passed completely through the assembly.Performed per the ifu provided with the kit, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guide wire due to ars resistance could not be performed as only representative samples were returned for analysis.Visual analysis did not reveal any defects or anomalies on the returned sample.The returned guide wire also met all relevant dimensional and functional requirements.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, the root cause cannot be determined as the actual guide wire/ars involved with this event was not returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on 13 sep 2024, the doctor found the resistance when the swg inserted into the ars during use on the same patient.The swg was found kinked when withdrawing the swg.They changed a new one to resolve the issue." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER SUBCLAVIAN
• 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 Key: 20491054
• Report Number: 3006425876-2024-01020
• Device Sequence Number: 17170191
• Product Code: LFJ
• UDI-Device Identifier: 00801902100146
• UDI-Public: (01)00801902100146(11)230417(17)280331(10)71F23D0709(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K895417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 71F23D0709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown