MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06840-U
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the catheter into the patient, the pump alarmed helium loss 2.After the catheter was removed, it was found that the front end of the balloon was bent".Additional information states that the iab catheter was replaced into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed ziploc bag.Up-on return, the teflon sheath was noted on the iabc outer lumen.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.No blood was noted on the exterior sur-faces of the returned sample.No obvious blood was noted within the helium pathway.No visual damage or abnormalities were noted to the returned sample.The sample was likely cleaned prior to its return.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.No leaks were detected.Full inflation was achieved.The device passed the leak test.The iabc was connected to an iabp with a lab inventory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.The iabc was pumped for a minimum of 15 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to ad-vance 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 alarmed helium loss 2" is not confirmed.During the investigation, the returned iab catheter was fully intact.No leaks or alarms were detected during the functional testing.The returned device passed visual and functional test specifications.Based on a re-view of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.
Event or Problem Description
It was reported "after the catheter into the patient, the pump alarmed helium loss 2.After the catheter was removed, it was found that the front end of the balloon was bent".Additional information states that the iab catheter was replaced into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 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: 23644330
• Report Number: 3010532612-2025-01169
• Device Sequence Number: 18556846
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: (01)00801902026804(11)240913(17)260831(10)18F24J0045(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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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-06840-U
• Device Lot Number: 18F24J0045
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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