MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI JACC KIT: 3-L 6 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-42063-JX1A
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "clinician accessed vessel with introduced needle and visualized blood return.When attempting to feed the guidewire through the introducer needle it would not advance past the floppy end.Introducer needle and guidewire had to be removed from patient as one unit.When examining the guidewire a 'bur' or 'seam' was noticed and felt at the floppy end.An 80cm hydrophilic guidewire was dropped single sterile to complete the procedure.2nd stick was successful with 80cm guidewire." the patient's current condition is unknown at this time.Associated mdr numbers include: 9680794-2025-00367.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported "clinician accessed vessel with introduced needle and visualized blood return.When attempting to feed the guidewire through the introducer needle it would not advance past the floppy end.Introducer needle and guidewire had to be removed from patient as one unit.When examining the guidewire a 'bur' or 'seam' was noticed and felt at the floppy end.An 80cm hydrophilic guidewire was dropped single sterile to complete the procedure.2nd stick was successful with 80cm guidewire." the patient's current condition is unknown at this time.Associated mdr numbers include: 9680794-2025-00367 and 9680794-2025-00409.

• Brand Name: ARROW AGBA PI JACC KIT: 3-L 6 FR X 20 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 21926069
• Report Number: 9680794-2025-00409
• Device Sequence Number: 15632035
• Product Code: LJS
• UDI-Device Identifier: 60801902123888
• UDI-Public: (01)60801902123888(11)240905(17)260131(10)33F24D0922(21)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: CDC-42063-JX1A
• Device Lot Number: 33F24D0922
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2024
• 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