MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06830-U
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported ", during the catheter use, the pump reported the helium loss alarm.Change the new catheter".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 on the returned sample is (b)(6).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that does not match the serial number of the returned sample.The sample was returned within 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 unwrapped.The iabc central lumen was noted bent at approximately 12.3cm and 21.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No other visual damage or abnormalities were noted to the returned sample.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 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.Resistance was noted at approximately 12.3cm and 21.8cm 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 manufacturing specifications prior to release.The reported complaint that the "pump reported the helium loss alarm" 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 corrective and preventive action (capa) has been initiated to address the issue.
Event or Problem Description
It was reported ", during the catheter use, the pump reported the helium loss alarm.Change the new catheter".No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 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: 23829472
• Report Number: 3010532612-2025-01242
• Device Sequence Number: 17416535
• Product Code: DSP
• UDI-Device Identifier: 10801902145625
• UDI-Public: (01)10801902145625(11)231221(17)251130(10)18F23M0044(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• 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): 11/24/2025

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: 11/30/2025
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23M0044
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown