MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05850-LWS-SC
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "balloon failed to inflate.Manual inflation preformed, balloon still did not fully inflate".No patient injury or cosnequence reported.The patient's current condition is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 8fr fiberoptix ultra (sc) intra-aortic balloon catheter (iabc) without the original packaging carton.The sample was returned in a cardboard box and was in a bio-hazard 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.Bends to the central lumen were noted at approximately 15cm, 57cm, 69cm and 73.3cm.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the blad-der/helium pathway.The fos cable was visually inspected; no damage or abnormalities were noted.The fos (sc) connector was examined.The fos white connector was properly seated in the blue clamshell housing.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The bladder thickness was measured at six points with measurements ranging from 0.0065in-0.0068in and was within specification of pro-cess 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 catheter's cen-tral lumen was aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was connected to an iabp with a lab inventory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpressure was applied.After the pumping was initiated, the iabc bladder was noted not fully inflating/unwrapping and was consistent with being twisted at the proximal and distal ends of the bladder.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detected from the returned sample.The device passed the leak test; however, during the leak test, the bladder did not fully inflate.The middle portion of the bladder had inflated but the distal and proximal portion of the bladder would not fully unwrap and was consistent with being twisted.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.The guidewire met resistance and could not advance at approximately 72cm from the iabc distal tip, which is the location of the previously noted bend.No blood or debris was noted on the guidewire.The guide-wire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 9.4cm from the iabc luer, which is the location of the previously noted bend.No blood or debris was noted on the guidewire.Destructive testing was performed by man-ufacturing and qa engineers to determine the cause of the bladder's failure to fully inflate.During the destructive test, the iabc bladder was cut and removed from the iabc distal tip.Upon further testing, the flex-tip was able to spin.The wire-round was removed from the flex tip assem-bly/central lumen.Under microscopic inspection, a portion of the inner cannula was noted not to be properly sanded.Adhesive appeared to be present on the inner cannula and inside the polyimide; however, the adhesive appeared localized on either side of the polyimide bond.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 "balloon failed to inflate" is confirmed.During the investigation, the proximal and distal portion of the iabc bladder was noted twisted and the bladder would not fully inflate or unwrap 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 dur-ing the complaint investigation due to the twisted bladder.The probable root cause of the com-plaint is manufacturing related.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported "balloon failed to inflate.Manual inflation preformed, balloon still did not fully inflate".No patient injury or consequence reported.The patient's current condition is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 50CC
• 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: 24687109
• Report Number: 3010532612-2026-00243
• Device Sequence Number: 9706517
• Product Code: DSP
• UDI-Device Identifier: 10801902218923
• UDI-Public: (01)10801902218923(11)251118(17)271031(10)18F25L0022(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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 Catalogue Number: IAB-05850-LWS-SC
• Device Lot Number: 18F25L0022
• 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: 11/18/2025
• 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.
• Patient Sex: Unknown