MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05830-LWS-SC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "leaking sheath and balloon wouldn't go through".It is unknown from the customer as how this issue was resolved.The patient's condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 8.0fr fiberoptix ultra (sc) intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number of the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging car-ton/sealed bio-hazard bag.Returned with the sample was supplied teflon sheath and dilator.Upon return, the one-way valve was tethered to the short driveline tubing.The supplied 30cc inflation driveline tubing was noted connected to the short driveline tubing.The iabc bladder was fully un-wrapped.Dried blood was noted on the exterior surfaces of the returned iabc.No blood was noted within the helium pathway.No visual damage or abnormalities were noted to the returned iab cathe-ter.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 returned dilator was visually inspected with no damage or abnormalities noted.The hub and tip of the returned dilator was typical.The returned teflon sheath was visually in spected.The returned teflon sheath extrusion was noted damaged at mul-tiple locations; the damage is consistent with being buckling to the sheath extrusion.It could not be confidently determined how the buckling occurred to the sheath extrusion.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 ac-cording to quality system document.The fos (sc) connector was connected to the iabp and the iabp zeroed the iabc.The pump status displayed "ok" indicating the fiber is fully intact.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufactur-ing 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 advance through the central lumen.No blood or debris was noted.The returned teflon sheath was inserted in the t-tube and the t-tube was pressurized to 300mmhg.No leaks were detected from the sheath and sheath sidearm.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 compliant sheath damaged is confirmed.During the investigation, the teflon sheath extrusion was noted damaged consistent with buckling at multiple locations.It could not be confi-dently determined how the buckling occurred to the sheath extrusion.A buckled sheath extrusion can cause difficulty inserting the iab catheter through the sheath.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 damaged/buckled sheath extrusion.The root cause of the damaged/buckled sheath extrusion is undetermined; a potential root cause is customer handling.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "leaking sheath and balloon wouldnt go through".It is unknown from the customer as how this issue was resolved.The patient's condition is reported as "fine".

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 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: 22700424
• Report Number: 3010532612-2025-00715
• Device Sequence Number: 9037413
• Product Code: DSP
• UDI-Device Identifier: 10801902218909
• UDI-Public: (01)10801902218909(11)250226(17)270131(10)18F25B0076(21)
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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-05830-LWS-SC
• Device Lot Number: 18F25B0076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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