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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "after the catheter inserted into the patient, the pump alarmed helium leakage 3.After remove the catheter, the front of balloon is bent.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).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was in a ziploc bag.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iab central lumen was noted broken at multiple locations.The central lumen was noted broken at approximately 1.6cm and 5.2cm from the distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0061in and was within specification of process document.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.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation, consistent with previously confirmed broken central lumen.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immedi-ately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; a leak was immediately detected from the bladder membrane.Under microscopic inspection, abrasions were observed from approximately 22.5cm to 23.1cm from the iabc distal tip; a full thickness abrasion to the bladder was confirmed at approximately 22.6cm from the iabc distal tip and the appearance is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected.It could not be confidently determined which damage occurred first.A lab inventory 0.025in guidewire was front loaded through the iabc luer.The guidewire met resistance at 9.3cm and 17.9cm from the iabc luer.Then the guidewire exited the central lumen and entered the bladder at the location of the broken central lumen.No blood and debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The de-vice passed all manufacturing specifications prior to release.The reported complaint for "the pump alarmed helium leakage 3" is confirmed.Upon return, the central lumen was noted broken at multiple locations and during the investigation, a leak site consistent with repeated contact with calcified plaque on the aortic wall was noted on the bladder membrane.Due to the returned state of the device, it could not be confidently determined which damage occurred first or what initially caused the complaint.Based on a review of the de-vice history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the leaks.The root cause of the complaint is undetermined.This will be monitored for any developing trends.
Event or Problem Description
It was reported " after the catheter inserted into the patient, the pump alarmed helium leakage 3.After remove the catheter, the front of balloon is bent.Change the new catheter".No patient injury or consequnece 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: 24428178
• Report Number: 3010532612-2026-00147
• Device Sequence Number: 8159279
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)250205(17)270131(10)18F25B0001(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): 01/28/2026

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-06840-U
• Device Lot Number: 18F25B0001
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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