MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05830-LWS-SC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "catheter did not work, ended up inserting another catheter that worked fine.They were getting high pressure alarms with the first.Checked connections and did not see any kinks in the tubing".As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 8fr fiberoptix ultra intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number for the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Returned with the sample was the supplied 30cc driveline tubing.Upon return, the one-way was tethered and connected to the short driveline tubing.The bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The fos cable was visually inspected; no damage or abnormalities were noted.The fos (sc) connector was examined.The fos white connector was properly seated in the blue clamshell housing.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was connected to an iabp using a lab inventory 30cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.The iabc was pumped for a minimum of 30 minutes.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.The iabc was leak tested.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was 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 "high pressure alarms" is not confirmed.The returned intra-aortic balloon catheter (iabc) passed functional test specifications.The returned iabc bladder was fully intact with no abnormalities noted.During the investigation, the iabc fully inflated, and no leaks were detected.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action is required at this time.Other remarks: corrected data:.

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23414700
• Report Number: 3010532612-2025-01059
• Device Sequence Number: 21407470
• Product Code: DSP
• UDI-Device Identifier: 10801902218909
• UDI-Public: (01)10801902218909(11)250303(17)270228(10)18F25B0140(21)
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 10/03/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAB-05830-LWS-SC
• Device Lot Number: 18F25B0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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
• Patient Sex: Unknown