MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3L 7 FR X 8 IN AGB+; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-45703-PRGK1
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the clinician attempted to advance the "j-tip" portion of the spring wire guide (swg) through the guide wire advancer using their thumb, however, the wire would not advance.The clinician noted that the "j-tip" appeared less stiff than expected.The clinician removed the guide wire from the advancer and manually straightened the "j-tip" before inserting it directly into the introducer needle.Some resistance was encountered while advancing the swg through the introducer needle; however, successful vascular placement was achieved.The clinician was able to remove the introducer needle, perform dilation over the swg, advance the catheter, and complete the procedure without further complication.After removal, the swg was inspected and found to be intact, although abnormalities were noted at the "j-tip" portion.No patient injury, harm, or adverse health consequences were reported.The patient's condition was reported as fine, and no additional medical intervention was required.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW PI CVC KIT: 3L 7 FR X 8 IN AGB+
• 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: 25444072
• Report Number: 9680794-2026-00441
• Device Sequence Number: 14937135
• Product Code: LRS
• UDI-Device Identifier: 10801902136654
• UDI-Public: (01)10801902136654(11)251125(17)270131(10)33F25J0300(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: ASK-45703-PRGK1
• Device Lot Number: 33F25J0300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2025
• 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.
• Patient Sex: Unknown