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

Catalog Number	IAB-05840-LWS-SC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "iabc abrasion/rupture.She placed me on speaker with the md.A large amount of blood was noted in the helium drive line immediately after insertion on initiation ofpumping.Alarms were noted on the pump.Md discussed why this could occur and commented that he noteddifficulty during insertion due to severe iliac disease".Additional information states that the information catheter was removed and not replaced.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The serial number recorded on the complaint report matches the serial number on the returned sample.Returned for investigation was a 40cc 8fr fiberoptix ultra (sc) intra-aortic balloon catheter (iabc) with the original packaging label that matches the serial number of the returned sample.The sample was returned in the ups shipping box and was in a sealed bio-hazard bag.Returned with the sample was supplied 40cc inflation driveline tubing; dried/liquid blood was noted within the returned inflation driveline tubing.Upon return, the iabc bladder was noted withdrawn through the teflon sheath and the sheath was noted on the section of the iabc bladder membrane; the sheath sidearm was noted cut and the remaining length of the sidearm was not returned with the sample.The iabc short driveline tubing was noted cut; the remaining length of the cut short driveline tubing including the one-way valve was noted connected to the returned inflation driveline tubing and the one-way valve was tethered to the cut section of the short driveline tubing.The visible section of the bladder was fully unwrapped.A bend to the iabc central lumen within flex tip assembly area was noted at approximately 5.2cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried/liquid blood was noted within the helium pathway.No other visual damage or abnormalities were noted to the returned sample.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 0.0056in-0.0064in 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 (b)(4).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 no ted.Upon receipt, the teflon sheath was noted on a section of the bladder membrane, however, there is no evidence that the user attempted to remove the iabc and bladder through the sheath.The teflon sheath was moved towards the iabc bifurcate without any difficulty.Upon removal, the covered portion of the bladder was fully wrapped, and no visual damage was noted iabc bladder.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, a leak site consistent with contact from a sharp object was noted at approximately 2.2cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Re-sistance was noted at approximately 5.4cm from the iabc distal tip, which is the location of the pre-viously noted bend.The guidewire was able to advance through the central lumen.No blood or de-bris 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 for "blood in the helium drive line" is confirmed.During the investigation, a puncture consistent with contact from a sharp object, was found on the distal end of the bladder.The damaged bladder allowed blood to enter the helium pathway.Based on a review of the device histo-ry record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the bladder leak.The probable root cause is customer handling related.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "iabc abrasion/rupture.She placed me on speaker with the md.A large amount of blood was noted in the helium drive line immediately after insertion on initiation ofpumping.Alarms were noted on the pump.Md discussed why this could occur and commented that he noteddifficulty during insertion due to severe iliac disease".Additional inforamtion states that the iab catheter was removed and not replaced.The patient's current condition is reported as "fine".

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB: 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: 22851475
• Report Number: 3010532612-2025-00776
• Device Sequence Number: 12862895
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: (01)00801902007247(11)240918(17)260831(10)18F24J0032(21)
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: IAB-05840-LWS-SC
• Device Lot Number: 18F24J0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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: Male