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

Catalog Number	IAB-05830-LWS-SC
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "helium 2 loss alarm on iabp.Switched the console on and off again and still wouldn't work.It wasn't ruptured as we removed it and inflated it manually to check for leaks.This happened once we had placed it in the patient but unfortunately due to the alarm, the surgeon removed the catheter and didn't want to replace it".The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "helium 2 loss alarm on iabp.Switched the console on and off again and still wouldn't work.It wasn't ruptured as we removed it and inflated it manually to check for leaks.This happened once we had placed it in the patient but unfortunately due to the alarm, the surgeon removed the catheter and didn't want to replace it".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 8fr fiberoptix ultra (sc) intra-aortic balloon catheter (iabc) without the original packaging carton.The sample was returned in a cardboard box and was in a yel-low plastic bag.Upon return, the iabc bladder was noted withdrawn through the teflon sheath and the sheath was noted on the iabc bladder membrane.Buckling was noted to the teflon sheath ex-trusion.; blood was noted in the sidearm.The visible portion of the bladder was unwrapped.The one-way valve was tethered to the short driveline tubing.The outer lumen was noted damaged at approx-imately 41cm to 43.5cm from the luer end.Dried blood was noted on the exterior surfaces of the re-turned sample.No blood was noted within the bladder/helium pathway.The fos cable was visually inspected.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fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The iabc bladder was noted withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion, which indicates the iabc was not removed from the patient correctly per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." 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 according to quality system document.The one-way valve was connected to the short driveline tubing, and a negative vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was entirely removed from the catheter.Upon removal, the central lumen was noted broken at approximately 5.5cm from the iab dis tal tip.In addition, the fiber was also not-ed broken at approximately 72cm from the iabc luer end.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation, which is consistent with the broken central lumen.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire exit-ed the central lumen and entered the bladder at the location of the broken central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire exited the central lumen and entered the bladder at the location of the broken 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 re-lease.The reported complaint for helium loss alarm is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc distal tip, which can cause the reported alarm.Unrelated to the reported complaint, the returned iabc bladder was found with-drawn through the teflon sheath and buckling was noted to the teflon sheath extrusion.This indi-cates the user did not follow the instructions for use (ifu) and could result in damage to the device.As a result, an in-service has been requested to review the ifu with the customer.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 broken central lumen.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): TELEFLEX MEDICAL; 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: 23475833
• Report Number: 3010532612-2025-01071
• Device Sequence Number: 16074142
• Product Code: DSP
• UDI-Device Identifier: 10801902218909
• UDI-Public: (01)10801902218909(11)240910(17)260831(10)18F24H0164(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 08/31/2026
• Device Catalogue Number: IAB-05830-LWS-SC
• Device Lot Number: 18F24H0164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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