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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported ", the catheter was inserted into the patient and the patient was transferred to the intensive care unit after the surgery.The balloon was found leakage".Additional "information" states that the iab catheter was removed and not replaced.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported ", the catheter was inserted into the patient and the patient was transferred to the intensive care unit after the surgery.The balloon was found leakage".Additional information states that the iab catheter was removed and not replaced.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 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 bio-hazard bag.Upon return, the one-way valve tethered to the short driveline tubing.The bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the helium pathway.No visual damage or abnormalities were noted to the return sample.The customer submitted video was reviewed.In the video, the user performed the leak test outside the patient and under the liquid bath.The iabc bladder was noted leaking near the proximal end of the bladder, which is consistent with the reported event.The bladder thickness was measured at six points with measurements ranging from 0.0059in-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.Blood clot exited.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the bladder membrane.Under microscopic inspection, abrasions were observed from approximately 24.1cm to 25cm from the iabc distal tip; a full thickness abrasion to the bladder was confirmed at approximately 24.5cm from the iabc distal tip and the appearance is consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance 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 manufacturing specifications prior to release.The reported complaint that the "balloon was found leakage" is confirmed.During investigation, the intra aortic balloon catheter (i abc) bladder was found with a full thickness abrasion.The ap-pearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.The damaged bladder allowed blood to enter the helium pathway.No other leaks were detected during functional testing.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 investigation due to the bladder leak.The root cause of the bladder leak is related to patient condition.No further action required at this time.This will be monitored for any developing trends.

• 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: 24512206
• Report Number: 3010532612-2026-00188
• Device Sequence Number: 9943453
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)250410(17)270331(10)18F25D0024(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): 02/04/2026

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-06840-U
• Device Lot Number: 18F25D0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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