MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05840-U
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "persistent helium loss 2 alarms'.Additional information states that the iab catheter was removed and not replaced due the patient no longer needing iab support.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The serial number identified in the customer submitted photo is (b)(6) and matches with the serial number on the returned sample.Returned for investigation was a 40cc 8fr ultra intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the teflon sheath was noted on the iab catheter; liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.A non-teleflex short arterial pressure tubing was noted connected to the iabc luer.The iabc bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned iabc; no blood was noted within the helium pathway.No visual damage or abnormalities were noted to the returned sample.The customer submitted photo was reviewed.The photo shows the iabc serial number.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 and then 30 seconds five separate times in accordance with quality system document.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.An external leak was immediately detected from the distal end of the bifurcate bushing.Under microscopic inspection, the leak from the bifurcate bushing occurred from the adhesive bond.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 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 for "persistent helium loss 2 alarms" is confirmed.During the complaint investigation, an external helium leak was confirmed from the intra-aortic balloon catheter (iabc) bifurcate bushing adhesive, which resulted in the helium loss alarm and caused the reported complaint.The iabc bladder was fully intact with no damage or abnormalities were noted.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 external leak from the iabc bifurcate bushing adhesive.The probable root cause is manufacturing related.A corrective and preventive action has been initiated to address the issue.
Event or Problem Description
It was reported "persistent helium loss 2 alarms'.Additional information states that the iab catheter was removed and not replaced due the patient no longer needing iab support.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW ULTRA 8 IAB: 8FR 40CC
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21054987
• Report Number: 3010532612-2025-00005
• Device Sequence Number: 21026420
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: (01)00801902010759(11)231012(17)250930(10)18F23K0012(21)
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• 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,Followup
• Report Date (Section B): 12/06/2024

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: IAB-05840-U
• Device Lot Number: 18F23K0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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: Male