MAUDE Adverse Event Report: Arrow International LLC ARROW PACING/PSI KIT: 5 FR 2-L; CATHETER, ELECTRODE RECORDING

Catalog Number	AI-07155-KS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Bacteremia (4846)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in the cvicu, nursing staff observed intravenous fluid and blood leaking into the cath-gard contamination shield while the temporary transvenous pacing (tvp) system was in use.The tvp had been in place for approximately 24 hours when the issue was identified and was subsequently removed on (b)(6)2026.The patient experienced an unknown amount of blood loss; however, no blood transfusion or administration of blood products was reported.It was further reported that the patient became febrile and was subsequently diagnosed with a central line-associated bloodstream infection (clabsi).The patient received intravenous antibiotic treatment from (b)(6)2026 through (b)(6)2026.The patient subsequently underwent permanent pacemaker placement(ppm) and was discharged home on (b)(6)2026, with a subsequent discharge reported on (b)(6)2026.No additional medical or surgical interventions were reported beyond those described above.
Additional Manufacturer Narrative
Continuation of d11: ent from (b)(6)2026 through (b)(6)2026.Qn#(b)(4).

• Brand Name: ARROW PACING/PSI KIT: 5 FR 2-L
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 50088596
• Report Number: 9680794-2026-00596
• Device Sequence Number: 18721303
• Product Code: OES
• UDI-Device Identifier: 10801902004533
• UDI-Public: (01)10801902004533(11)260305(17)270731(10)33F26B0938
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: AI-07155-KS
• Device Lot Number: 33F26B0938
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2026
• 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: The patient received intravenous antibiotic treatm
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown