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	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the balloon could not be fully inflated.".Additional information states that the iab catheter was removed and replaced to continue therapy.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the balloon could not be fully inflated.".Additional information states that the iab catheter was removed and replaced to continue therapy.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).Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a clear plastic bag.Upon return, the iabc bladder was noted withdrawn through the teflon sheath and the sheath was noted on the iabc bladder membrane.The one-way valve was tethered to the short driveline tubing.The exposed portion of the bladder was fully unwrapped.Multiple bends to the iabc central lumen were noted at ap-proximately 5cm, 16cm, 26.5cm, 38cm, 48cm and 58cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No other visual damage or abnormalities were noted to the returned sam-ple.The iabc bladder was noted withdrawn through the teflon sheath, which indicates the iabc was not removed from the patient correctly per the instructions for use (ifu).As a result, an in-service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.The instruc-tions for use (ifu) states:"do not remove arrow iab through hemostasis 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 bal-loon damage." the customer submitted video was reviewed.The video shows the iabc bladder under fluoroscopy and the bladder was not fully inflating near the iabc distal tip during pumping.The bladder thickness was measured at six points with measurements ranging from 0.0063in-0.0065in 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.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 blad-der.The returned iabc was unable to be pump tested due to the multiple bends noted to the iabc.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.Resistance was noted at approximately 4.9cm and could not advance at approximately 16.2cm from the iabc distal tip, which are the locations of the previously noted bends.No blood or debris was noted.The guide- wire was front loaded through the iabc luer.Resistance was noted at approximately 14.1cm and could not advance at approximately 27.5cm from the iabc luer, which are the locations of the previously noted bends.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 that the "balloon could not be fully inflated" is confirmed based on the customer provided video with the complaint report.In the video, the iabc bladder was noted not fully inflating near the iabc distal tip; however, during the investigation, the iabc fully inflated, and no leaks/alarms were noted.The returned device passed visual and functional test specifica-tions.Unrelated to the reported complaint, the returned iabc bladder was found withdrawn through the teflon sheath.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.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 complaint 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: 24471001
• Report Number: 3010532612-2026-00171
• Device Sequence Number: 9506707
• Product Code: DSP
• UDI-Device Identifier: 10801902145625
• UDI-Public: (01)10801902145625(11)250729(17)270630(10)18F25G0093(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 02/01/2026

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: 18F25G0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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