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

Model Number	IPN920509
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we have had two incidents with the vectorflow catheter.In both cases, the peelable introducer, which comes with the catheter kit, broke.There are two units.The incident occurred during surgery.The patient was not injured or suffered any adverse consequences, nor did he require further medical intervention." the patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, and 9680794-2025-00329.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer submitted four photos for analysis.The images show a 16fr smartseal sheath.One tab of the sheath has broken off from the sheath body.The edges of the remaining sheath extrusion are warped/stretched.This damage is consistent with incorrect tearing of the sheath.Therefore, the report of incorrect tearing of a peel-away sheath is confirmed.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and there was one potential finding.A scar was initiated for failure mode "peel-away sheath tears incorrectly".Review confirmed that the failure mode of this complaint matches that addressed in the scar.The instructions for use (ifu) provided with this kit instructs the user "sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the customer report of incorrect tearing of a peel-away sheath was confirmed by visual inspection of the customer supplied photos; however, full 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.A scar was issued on 11-apr-2024 regarding "peel-away sheath tears incorrectly".The device addressed in this complaint was manufactured on 11-aug-2023; therefore, this device was manufactured prior to corrective action implementation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "we have had two incidents with the vectorflow catheter.In both cases, the peelable introducer, which comes with the catheter kit, broke.There are two units.The incident occurred during surgery.The patient was not injured or suffered any adverse consequences, nor did he require further medical intervention." the patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2025-00314, 9680794-2025-00315, 9680794-2025-00330, and 9680794-2025-00329.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• 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: 21889115
• Report Number: 9680794-2025-00314
• Device Sequence Number: 19684480
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)230823(17)260731(10)33F23G0532(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 03/28/2025

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: 07/31/2026
• Device Model Number: IPN920509
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23G0532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Male