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 Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "iabp balloon inserted into patient; connected to gentige iabp machine, able to start augmentation initially.Iabp machine alert: circuit leak.External circuit checked, connections secure, no obvious leak.Unable to augment.Noticed blood in helium lumen, suggestive of breach between helium lumen and blood lumen.Iabp balloon immediately removed from patient".No patient injury or consequence reported.The patient's current condition is reported as "unknown".
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 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging box.The sam-ple was returned in a cardboard box and was in a ziploc bag.Upon return, the teflon sheath was noted on the iabc.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the central lumen was noted at approximately 49cm from the distal tip.The iabc central lumen was noted broken within the flex-tip assembly area at approximately 6cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The customer photos were reviewed.The photo shows the iab catheter.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.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 lu-men.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.A leak was im-mediately 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 luer end blocked off; no other leaks were de-tected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No re-sistance was noted; the guidewire exited the central lumen and entered the bladder at the loca-tion of the broken central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire exited the central lumen and entered the bladder at the location of the broken central lumen.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number/serial number with no rel-evant findings.The device passed all manufacturing specifications prior to release.The reported complaint that the "blood in helium lumen, suggestive of breach be-tween helium lumen and blood lumen" is confirmed.During the investigation, the iabc central lumen was noted damaged within the iabc flex-tip assembly area.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifi-cations were not met during the complaint investigation due to the damaged central lumen.The probable root cause of the complaint is manufacturing related.Corrections have been established for this issue as a result of a corrective and preventive action, and this device was manu-factured prior to the release of corrective actions.
Event or Problem Description
It was reported "iabp ballon inserted into patient connected to gentige iabp machine able to start augmentation initially.Iabp machine alert: circuit leak.External circuit checked, connections secure, no obvious leak.Unable to augment.Noticed blood in helium lumen, suggestive of breach between helium lumen and blood lumen iabp balloon immediately removed from patient".No patient injury or consequence reported.The patient's current condition is reported as "unknown".

• 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: 24689932
• Report Number: 3010532612-2026-00252
• Device Sequence Number: 18554967
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)240310(17)260228(10)18F24C0006(21)
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 02/28/2026
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F24C0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown