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	09/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the pump alarm indicated helium leakage.After consulting with the engineer, an attempt was made to adjust the position of the balloon, and the pump was restarted.However, the alarm of helium leakage still occurred.After replacing the new catheter, the pump resumed normal operation.When the first catherer was removed, it was found that the front section had been bent and could not be restored to its original state".No patient injury or consequence reported.The patient's current condition is reported as "fine.".
Event or Problem Description
It was reported "the pump alarm indicated helium leakage.After consulting with the engineer, an attempt was made to adjust the position of the balloon, and the pump was restarted.However, the alarm of helium leakage still occurred.After replacing the new catheter, the pump resumed normal operation.When the first catherer was removed, it was found that the front section had been bent and could not be restored to its original state".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).The lot number for the returned sample is 18f25a0056.Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 30cc 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 teflon sheath was noted on the iabc; blood was noted in the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The central lumen was noted broken at approximately 5.2cm from the iab distal tip.A bend to the central lumen was noted at approximately 51cm from the distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Some blood was noted within the bladder/ helium pathway.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.Dried blood was noted within the one-way valve.The catheter's 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.A leak was immediately detected from the iabc distal tip.The leak from the iabc distal tip is 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.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.2cm from the iab distal tip, which is the location of the previously noted broken central lumen.The catheter was able to advance through the central lumen and exit through the luer end.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 for "the pump alarm indicated helium leakage" is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc distal tip, which allowed blood to enter the helium pathway and can cause the reported alarm.Based on a review of the device history record (dhr), the product met specification upon release; how-ever, the specifications were not met during the complaint investigation due to the broken central lumen.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• 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: 23347045
• Report Number: 3010532612-2025-01030
• Device Sequence Number: 13129081
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250123(17)261231(10)18F25A0056(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): 09/25/2025

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-06830-U
• Device Lot Number: 18F25A0056
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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