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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 8fr fiberoptix ultra (sc) intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Upon return, the one-way valve was tethered to the short driveline tubing.The iabc bladder was fully un-wrapped.Two bends to the iabc central lumen were noted at approximately 19cm and 22.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.No other visual damage or abnormalities were noted to the returned sample.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 according to quality system document.The fos (sc) connector was connected to the iabp.The pump status displayed "not connected".Upon further checking, the fiber was found broken at approximately 23.7cm from the iabc distal tip.The full length of the fiber was confirmed present with no other no-table breaks.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abno rmalities or debris were noted.The iabc was leak tested in accordance with testing meth-ods from manufacturing procedure.An external leak was immediately detected from the distal end of the bifurcate bushing.Under microscopic inspection, the leak from the bifur cate 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.Resistance was noted at approximately 19.2cm and 22.7cm from the iabc distal tip, which are the locations of the previously noted bends.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 manufac-turing specifications prior to release.The reported complaint for "helium leak, would not hold gas" is confirmed.During the complaint investigation, an external helium leak was confirmed from the intra-aortic balloon catheter (iabc) bifurcate bushing adhesive, which caused the reported complaint.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 cor-rective and preventive action (capa) has been initiated to address the issue.
Event or Problem Description
It was reported that "helium leak, would not hold gas".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "helium leak, would not hold gas".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22609147
• Report Number: 3010532612-2025-00766
• Device Sequence Number: 5383914
• Product Code: DSP
• UDI-Device Identifier: 10801902218909
• UDI-Public: (01)10801902218909(11)241122(17)261031(10)18F24L0107(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 06/30/2025

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 Catalogue Number: IAB-05830-LWS-SC
• Device Lot Number: 18F24L0107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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