MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR; INTRODUCER CATHETER

Catalog Number	AK-09803-CDC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "incident in the icu where a catheter was introduced, but the valve failed to prevent air from entering the patient's system." the device was removed and replaced with a new cordis.There was no patient harm or injury.No medical intervention required.It was reported "the patient appears unaffected by this; she is critically ill but improving clinically.".
Additional Manufacturer Narrative
(b)(4).The customer returned one psi sheath for analysis.Signs of use in the form of biomaterial were observed.Visual analysis of the sheath did not reveal any obvious defects or anomalies.The hemostasis valve and psi were leak tested according to three different parameters per amrq-000037.Rev12: 1.) low pressure leak resistance (hemostasis valve), section 6.1.2, which states, "using a test pressure of 38-42 kpa (5.51-6.09 psi), there shall be no leakage past the hemostasis valve".The sheath/catheter was attached to the lab leak tester.With the distal end of the sheath occluded, the sheath was pressurized to 42 kpa for 30 seconds.No leaking was observed.2.) high pressure leak resistance test, section 6.1.3, which states, "when tested in accordance with iso 11070, annex d, using a test pressure of 300-320 kpa (43.5-46.4 psi) there shall be no leakage sufficient to form a falling drop".With both the distal end of the sheath and the hemostasis valve occluded with a lab inventory obturator, the device was pressurized to 320kpa for 30 seconds.No leaks were detected from any portion of the sheath, which indicates that the assembly is intact.3.) liquid leakage - hemostasis valve with a catheter inserted.A lab inventory 7 fr swan-ganz (outer diameter measured 0.088") was inserted into the valve of the sheath.The sheath was then pressurized to 42 kpa for 30 seconds.No leaking from the sheath was observed.A 0.085" pin gauge was inserted into the sheath valve.The sheath body was placed inside a beaker filled with water.A lab inventory syringe was then attached to the sheath side arm.The syringe was aspirated, and no air bubbles were observed.The sheath appears to aspirate as intended.The test above was repeated by holding the 0.085" pin gage at an angle.Upon aspiration, air bubbles were observed entering the lab inventory syringe.R & d was contacted and confirmed that psis of this type are designed to be compatible with all types of catheters; however, the orientation of the inserted catheter can possibly affect the functionality of the internal valve.It is recommended that the catheter be kept in a straight position while inserted in the sheath.A device history record review was performed, and no relevant findings were identified.The lidstock artwork was reviewed as part of this complaint.It states, "psi for use with 7.5fr.Catheters".The ifu provided with the kit informs the user, "indwelling devices should be routinely inspected for desired flow rate, security of dressing, correct position, and for secure luer_lock connection".The ifu also states, "hemostasis valve must be occluded at all times to reduce the risk of air embolism, contamination or hemorrhage.In the absence of an indwelling central catheter use the arrow obturator to occlude hemostasis valve".The report of a leaking valve during aspiration was not confirmed through analysis of the returned sample.Functional leak testing of the device in accordance with bs en iso 11070 did not reveal any leaks or anomalies of any kind.Likewise, no air bubbles were observed when aspirating the sample.Consultation from r & d revealed angled catheters can contribute to the customer observing air bubbles during aspiration.The inserted catheter size and the orientation at the time of the reported event are unknown; therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PSI KIT: 8.5 FR
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22912621
• Report Number: 9680794-2025-00727
• Device Sequence Number: 9130731
• Product Code: DYB
• UDI-Device Identifier: 20801902121756
• UDI-Public: (01)20801902121756(11)240312(17)251031(10)33F24A1016(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: 10/31/2025
• Device Catalogue Number: AK-09803-CDC
• Device Lot Number: 33F24A1016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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.
• Patient Sex: Unknown