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	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after catheter inserted, the pump triggered a helium leakage alarm.After troubleshooting connection and leakage issues, another pump was replaced, but the same alarm persisted.The catheter was replaced and functioned normally".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "after catheter inserted, the pump triggered a helium leakage alarm.After troubleshooting connection and leakage issues, another pump was replaced, but the same alarm persisted.The catheter was replaced and functioned normally".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The product was not returned for investigation.The customer photos were reviewed.The photo shows the iab label and is consistent with the reported lot number.The photos show an iabp display screen with a "possible helium loss 2" alarm, which is consistent with the reported com-plaint.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 leakage alarm" is confirmed based on the submitted photos.The product was not returned for investigation.The photos show an iabp display with a possible helium loss (2) alarm.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 inves-tigation due to the helium loss alarm.The probable root cause of the complaint is undetermined.No further action is required at this time.This will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.
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 an original packaging box that does not match the returned sample the sample was returned in a cardboard box and was loosely packed in the original carton.Upon return, the teflon sheath was on the returned iabc.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The customer photos were reviewed.The photo shows the iab label and is consistent with the reported lot number.The photos show an iabp display screen with a "possi-ble helium loss 2" alarm, which is consistent with the reported complaint.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 mi-nute 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 due to a blocked/ clotted central lumen.Upon aspiration, water was unable to be pulled into the syringe.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.The iabc was leak tested in accordance with testing methods from manufacturing procedure.An external leak was immediately noted and located around the distal end of the bi-furcate bushing adhesive bond.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.Some blood and debris were 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 "pump triggered a helium leakage alarm" is confirmed.During the in-vestigation, an external leak was confirmed from the intra-aortic balloon catheter (iabc) bifurcate bushing adhesive.The external leak could cause a helium loss alarm.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifica-tions were not met during the complaint investigation due to the external leak from the iabc bi-furcate bushing.The probable root cause of the complaint is manufacturing related.A corrective and preventive action has been initiated to further investigate the issue.
Event or Problem Description
It was reported "after catheter inserted, the pump triggered a helium leakage alarm.After troubleshooting connection and leakage issues, another pump was replaced, but the same alarm persisted.The catheter was replaced and functioned normally".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: 24482733
• Report Number: 3010532612-2026-00235
• Device Sequence Number: 4966918
• Product Code: DSP
• UDI-Device Identifier: 10801902145625
• UDI-Public: (01)10801902145625(11)241216(17)261130(10)18F24M0090(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,Followup
• Report Date (Section B): 02/02/2026

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-06830-U
• Device Lot Number: 18F24M0090
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/28/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/31/2026; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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