MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05840-LWS-SC
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "balloon failed to unwrap".Additional information states that the balloon catheter "eventually unwrapped".The iab catheter was not removed.No patient injury or consequence reported.The patient's current condition is reported as "critical".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 8fr fiberoptix ultra 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 and connected to the short driveline tubing.The bladder was fully unwrapped.Bends to the central lumen were noted at approximately 24cm and 49cm from the distal tip.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 hous-ing was examined, and no abnormalities were noted.The bladder thickness was measured at six points with measurements ranging from 0.0053in-0.0061in 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.An attempt to aspi-rate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be suc-cessfully completed due to a blocked/ clotted central lumen.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 connected to an iabp using a lab inventory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg backpres-sure was applied.The iabc was pumped for a minimum of 30 minutes.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.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 iabc distal tip.No resistance was noted; the guide-wire was able to advance through the central lumen.Some blood was noted.An attempt to aspi-rate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed before inserting the guidewire.Another attempt to aspirate and flush the catheter was successfully completed.A device history record (dhr) review was conducted for the lot num-ber/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint for "balloon failed to unwrap" is not confirmed.The returned intra-aortic balloon catheter (iabc) passed functional test specifications.The returned iabc bladder was ful-ly intact with no abnormalities noted.During the investigation, the iabc fully inflated, and no leaks were detected.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 is required at this time.
Event or Problem Description
It was reported "balloon failed to unwrap".Additional infomormation states that the balloon catheter "eventually unwrapped".The iab catheter was not removed.No patient injury or consequence reported.The patient's current condition is reported as "critical".

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 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: 24860176
• Report Number: 3010532612-2026-00335
• Device Sequence Number: 15712556
• Product Code: DSP
• UDI-Device Identifier: 10801902218916
• UDI-Public: (01)10801902218916(11)251003(17)270930(10)18F25J0129(21)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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-05840-LWS-SC
• Device Lot Number: 18F25J0129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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