MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number	CS-22142-CF
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2025, when the icu doctor at (b)(6) hospital affiliated to (b)(6) implanted the device, the guidewire got stuck in the puncture needle and could not be withdrawn.Therefore, the guidewire and puncture needle had to be withdrawn together, and a new catheter was re-inserted for catheterization.The customer said the swg unraveled, no harm for the patient.The patient condition is fine.Associated complaints (b)(4) and (b)(4).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The report that the guidewire got stuck in the needle was confirmed through examination of the returned sample.The customer returned one guidewire and one introducer needle for evaluation.The guidewire was returned partially advanced through the needle and was separated.The core and coil wires were broken near the distal end.The appearance of the separation points is consistent with damage resulting from retracting the guidewire back upon the needle bevel during use.The instructions-for-use (ifu) provided with this kit warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.".A device history record review was performed, and no relevant findings were identified.Arrow guidewires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the required standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the difficulty in advancing the guidewire.Based on these circumstances, unintentional use error caused or contributed to this event.
Event or Problem Description
It was reported that: "on (b)(6) 2025, when the icu doctor at (b)(6) hospital affiliated to (b)(4) implanted the device, the guidewire got stuck in the puncture needle and could not be withdrawn.Therefore, the guidewire and puncture needle had to be withdrawn together, and a new catheter was re-inserted for catheterization.The customer said the swg unraveled, no harm for the patient.The patient condition is fine.Associated complaints 3006425876-2025-01157 and 3006425876-2025-01160.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23828818
• Report Number: 3006425876-2025-01157
• Device Sequence Number: 21071395
• Product Code: MPB
• UDI-Device Identifier: 00801902100184
• UDI-Public: (01)00801902100184(11)241030(17)260809(10)71F24K0955(21)
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 08/09/2026
• Device Catalogue Number: CS-22142-CF
• Device Lot Number: 71F24K0955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/25/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown