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	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "balloon not inflating in body".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "balloon not inflating in body" is not able to be confirmed.The product was not returned for investigation.Based on a review 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.The reported c omplaint 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.
Event or Problem Description
It was reported "balloon not inflating in body".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).The lot number for the returned sample is 18f25b0002.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sample was returned in a cardboard box and was in a sealed ziploc bag.Upon return, the iabc bladder was noted withdrawn through the teflon sheath and the sheath was noted on the iabc bladder membrane; buckling was noted to the teflon sheath extrusion.The one-way valve was tethered to the short driveline tubing.The visible section of the bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the re-turned sample.No obvious blood was noted within the helium pathway.The iabc bladder was noted withdrawn through the teflon sheath and buckling was noted to the sheath extrusion, which indicates the iabc was not removed from the patient correctly per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.Th e instructions for use (ifu) states: "do not remove arrow iab through hemosta-sis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage.The bladder thickness was measured at six points with measurements ranging from 0.0056in-0.0063in and was within specification of process docu-ment.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 one-way valve was connected to the short driveline tubing, and a vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was moved from the iabc bladder and towards the bifurcate without any difficulty.Upon removal of the sheath, no damage or abnormalities noted to the iabc bladder.The iabc was connected to an iabp with a lab inven-tory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 75mmhg back-pressure was applied.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.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.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 manu-facturing specifications prior to release.The reported complaint that the "balloon not inflating in body" is not confirmed.The returned iabc bladder was fully intact with no abnormalities noted.During the investigation, the iabc fully inflated, and no leaks/ alarms were noted.The returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specifica-tion upon release.The root cause of the complaint is undetermined.No further action required at this time.Unrelated to the reported complaint, the returned iabc bladder was found withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion.This indicates the user did not follow the instructions for use (ifu) and could result in damage to the device.As a result, an in-service has been requested to review the ifu with the customer.
Event or Problem Description
It was reported "balloon not inflating in body".Additional information states that the iab catheter was removed and replaced.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: 23632890
• Report Number: 3010532612-2025-01160
• Device Sequence Number: 21411181
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: (01)00801902026804(11)250205(17)270131(10)18F25B0002(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/28/2025

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-06840-U
• Device Lot Number: 18F25B0002
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 02/25/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/23/2025; 04/03/2026
• 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
• Patient Sex: Unknown