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

Catalog Number	IAB-05830-LWS
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "kept alarming that there was a helium leak".The customer has been unable to provide any additional information sur rounding this event.
Additional Manufacturer Narrative
Qn#(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 8.0fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the ups shipping box and was in a sealed bio-hazard bag.Returned with the sample was supplied 30cc inflation driveline tubing; no damage or abnormalities were noted to the returned inflation driveline tubing.Upon return, the teflon sheath was noted on the iabc; liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.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 fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.The cal key was examined, and no damage was 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 and then 30 seconds five separate times according to quality system document.The cal key and fos were connected to the iabp.The cal key was recognized.The fos was connected and the iabp zeroed the iabc.The pump status displayed "ok" indicating the fiber is fully intact.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Some blood exited.The iabc was leak tested in accordance with testing methods from manufacturing procedure.An external leak was immediately detected from the bifurcate around the fos adhesive.Upon microscopic inspection, an external leak occurred from the fos adhesive bond at the bifurcate and was noted at two different locations, consistent with showing a void.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 "helium leak" is confirmed.During the investigation, an external helium leak was confirmed from the iabc bifurcate fos adhesive.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 leak at the bifurcate fos adhesive.The probable root cause of the bifurcate fos adhesive leak is manufacturing related.A corrective and preventive action (capa) has been initiated to further investigate the issue.
Event or Problem Description
It was reported "kept alarming that there was a helium leak".The customer has been unable to provide any additional information sur rounding this event.

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB: 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21343542
• Report Number: 3010532612-2025-00094
• Device Sequence Number: 7854724
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)240209(17)260131(10)18F24B0008(21)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 01/31/2026
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F24B0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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