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	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " the biggest problem is the tuohy that is supposed to tighten onto the pacing catheter does not get tight enough to keep the catheter in place, which allows the catheter to move with minimal effort.Blood backup into the swandom almost immediately after placement and continued after checking the tuohy was as tight as possible.Once a pressure bag was hooked up to the one patient, the entire swandom filled with fluid (it was described as looking like a long water balloon).The patient did fine until the next day; we got lucky that the catheter didn't move enough that it stopped capturing".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the biggest problem is the tuohy that is supposed to tighten onto the pacing catheter does not get tight enough to keep the catheter in place, which allows the catheter to move with minimal effort.Blood backup into the swandom almost immediately after placement and continued after checking the tuohy was as tight as possible.Once a pressure bag was hooked up to the one patient, the entire swandom filled with fluid (it was described as looking like a long water balloon).The patient did fine until the next day; we got lucky that the catheter didn't move enough that it stopped capturing".
Additional Manufacturer Narrative
(b)(4).The product was not returned for investigation.The customer submitted video was reviewed and shows an unused device which is deemed as a representative sample.In the video, the user fully tightened the tuohy borst adapter while the catheter was fully inserted; however, the catheter was moving freely and did not lock in position, which is consistent with the reported event.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 the "locking mechanism, even when fully tightened, does not secure the pacing wire in place" is confirmed based on the customer video provided with the complaint report.In the video, the user fully tightened the tuohy borst adapter while the catheter was fully inserted; however, the catheter was moving freely and did not lock in position.The device noted in the video was an unused device which is deemed as a representative sample.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the defective tuohy borst adapter.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

• 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 INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24429354
• Report Number: 3010532612-2026-00150
• Device Sequence Number: 16026615
• Product Code: DRF
• UDI-Device Identifier: 10801902004533
• UDI-Public: (01)10801902004533(11)250903(17)270131(10)33F25E0387(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/28/2026

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
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: 33F25E0387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2025
• 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: N/A.; N/A.
• Patient Sex: Unknown