MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during insertion, the doctor found the catheter tip deform, the catheter tip can't connect with the preloaded tunneler during used on the patient." they changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Event or Problem Description
It was reported that "during insertion, the doctor found the catheter tip deform, the catheter tip can't connect with the preloaded tunneler during used on the patient.".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.
Additional Manufacturer Narrative
(b)(4).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 complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4) the customer returned the body of a vectorflow hemodialysis catheter.The tunneling instrument was not returned.No obvious signs of use were observed.Visual analysis revealed that the catheter body had been cut at the cut-indication mark.The remaining portion of the catheter body, including the red catheter connector, was not returned for analysis.Microscopic examination of the distal tip of the catheter showed no obvious damage or deformation.No defects or abnormalities were observed on any portion of the returned device.Functional testing was unable to be performed as the red catheter connector portion of the catheter body was not returned for analysis.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, "securely attach red connector of catheter to tunneler tip.Ensure parts are securely snapped together before pulling catheter through tunnel tract." additionally, the ifu warns, "examine catheter and extension lines before and after each treatment for any signs of damage." the customer report of damage to the catheter tip was unable to be confirmed through investigation of the returned sample.Visual analysis of the distal tip of the returned catheter revealed no defects or abnormalities.The red catheter connector portion of the catheter body and the tunneling instrument were not returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the complete device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during insertion, the doctor found the catheter tip deform, the catheter tip can't connect with the preloaded tunneler during used on the patient.".They changed a new one to resolve the issue.No harm for the patient.The patient condition is fine.No medical intervention was required.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21719281
• Report Number: 9680794-2025-00261
• Device Sequence Number: 9492577
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: (01)10801902127171(11)240429(17)270331(10)33F24C0063(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141051
• 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,Followup
• Report Date (Section B): 03/10/2025

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 Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F24C0063
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 06/06/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/07/2025; 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• 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; NOT REPORTED
• Patient Sex: Unknown