MAUDE Adverse Event Report: Arrow International LLC ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL; INTRODUCER, CATHETER

Catalog Number	CDC-29903-XCN1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d11: n intravenous fluid bolus, laboratory testing, transfusion of 2 units of packed red blood cells (prbcs), 1 unit of fresh frozen plasma (ffp), 1 unit of cryoprecipitate, and 1 unit of platelets.Intravenous vasopressor support was administered for approximately 40 minutes.Manual and mechanical pressure were applied to the femoral insertion site for approximately 4 hours until removal of the psi sheath.The vasopressors were subsequently discontinued and later restarted approximately 12 hours thereafter.(b)(4).

• Brand Name: ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL
• Common Device Name: INTRODUCER, CATHETER
• 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: 50841582
• Report Number: 9680794-2026-00689
• Device Sequence Number: 9949773
• Product Code: OFC
• UDI-Device Identifier: 10801902179323
• UDI-Public: (01)10801902179323(11)260227(17)270831(10)33F26B0527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: CDC-29903-XCN1A
• Device Lot Number: 33F26B0527
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/21/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2026
• 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: Concomitant therapies and interventions included a.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 250 LB