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

Catalog Number	AI-07155-KS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "side infusion part won't give blood return.It sucks in large amounts of air form the site of the pacemaker wire ".Additional information states that another catheter was used to complete the procedure.At the time of this report, no additional information has been received from the customer.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 6fr.Psi sheath w/sidearm assembly from a 5fr.Pacing/psi kit.The sample was returned in a cardboard box and was in a clear plastic bag.Returned with the sam-ple was an inflation syringe.Upon return, the sheath extrusion was clamped off with a pair of for-ceps.A purple cap was noted on the sheath sidearm luer.Dried blood was noted on the exterior sur-faces of the returned sample.Some dried blood was noted within the interior surfaces of the returned sheath.The forceps was removed from the sheath extrusion.The sheath sidearm was aspirated and flushed successfully using a 60cc lab-inventory syringe.No blockage or abnormalities were noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint that "side infusion part won't give blood return" is not confirmed.The re-turned sheath passed functional test specifications.The sheath was able to be succesfully aspirated and flushed; no blockage or abnormalities wered noted.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is unde-termined.No further action is required at this time.
Event or Problem Description
It was reported that "side infusion part won't give blood return.It sucks in large amounts of air form the site of the pacemaker wire ".Additional information states that another catheter was used to complete the procedure.At the time of this report, no additional information has been received from the customer.

• Brand Name: 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 INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23742075
• Report Number: 3010532612-2025-01210
• Device Sequence Number: 15977616
• Product Code: DRF
• UDI-Device Identifier: 10801902004533
• UDI-Public: (01)10801902004533(11)240509(17)250930(10)33F24E0006(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K945229
• 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): 11/12/2025

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: 09/30/2025
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: 33F24E0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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
• Patient Sex: Unknown