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

Catalog Number	CS-25122-F
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "on (b)(6) 2026, during catheterization in the emergency internal medicine department of (b)(6) hospital, it was discovered that the guidewire was kinked.Despite attempts to operate, it could not be inserted.After confirmed with the customer.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".
Additional Manufacturer Narrative
(b)(4) the customer-reported guidewire kinking during use was confirmed through examination of the returned sample.The customer provided one photo and returned one guide wire along with 2 lumen 12 fr x 20 cm haemodialysis catheter for evaluation.Signs of use were observed on both the guidewire and catheter.Visual inspection identified four kinks in the guidewire body, three of which were severe.The distal j bend was misshapen.Dimensional inspection confirmed that the guidewire met all applicable specification requirements.Functional testing confirmed that resistance was encountered at the location of the severe kink and that the guide wire could not advance beyond the location of the kinks.A device history record review did not identify any manufacturing related issues.Based on the condition of the guidewire and the report that the damage was observed during use, the likely root cause is consistent with unintentional use error.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2026, during catheterization in the emergency internal medicine department of (b)(6) hospital, it was discovered that the guidewire was kinked.Despite attempts to operate, it could not be inserted.After confirmed with the customer.No harm for the patient.The patient condition is fine.No medical intervention was required.They changed a new one to resolve the issue.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 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: 24504921
• Report Number: 3006425876-2026-00262
• Device Sequence Number: 18756051
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: (01)00801902100207(11)250411(17)270207(10)71F25D0387(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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-25122-F
• Device Lot Number: 71F25D0387
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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