MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number	CU-22122-F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the doctor found the swg separated during use on the patient.They changed a new one.No impact for the patient." the device was removed entirely.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 for analysis.Signs-of-use in the form of biological material were observed on the guide wire tubing.Visual analysis revealed that the guide wire contained two major kinks towards the distal end.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.The kinks on the guide wire measured 538mm and 550mm from the proximal weld.The guide wire total length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.840mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The proximal end of the guide wire was inserted into the tip of the returned catheter.Resistance was encountered at the location of the kinks; however, the guide wire was able to pass completely through the catheter.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".A manual tug test confirmed that the distal and proximal welds were secure and intact to the coil and core wires.A device history record review was per-formed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested".The ifu also states, "if resistance is encountered when attempting to remove guidewire after catheter placement, guidewire may be kinked around tip of catheter within vessel".The report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was kinked in two locations towards the distal end.Despite the damage, the catheter met all relevant dimensional and functional requirements, and device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for re-ports of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected from (b)(4) to (b)(4).
Event or Problem Description
It was reported "the doctor found the swg separated during use on the patient.They changed a new one.No impact for the patient." the device was removed entirely.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER HEMODIALYSIS NON IMPL
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19476160
• Report Number: 3006425876-2024-00572
• Device Sequence Number: 6913368
• Product Code: MPB
• UDI-Device Identifier: 00801902100252
• UDI-Public: 00801902100252
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• 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): 05/15/2024

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 Expiration Date: 01/12/2025
• Device Catalogue Number: CU-22122-F
• Device Lot Number: 71F23A2932
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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