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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "difficulty passing catheter over the guidewire.Replaced the iab for another 50 cc fiberoptic sc iab.Once the iab was in place, they initiated the therapy and got a high-pressure alarm.They also had difficulty seeing the balloon fully inflate.They watched the iab for a few minutes and it seemed to be supporting the patient, but they continued to give high pressure alarms.They noted that the tip seemed to be fully inflating now.The patient was not on any vasopressors.The physician decided to replace the balloon using the same site.Replaced the balloon with a second 50 cc fiberoptic sc.They were able to get balloon placed without any difficulty.When they initiated therapy, they got high pressure alarms again.The tip was slow to fully inflate.The patient was getting support.They decided to reduce the balloon volume to 40 cc.There were no further alarms".No patient injury or consequence reported.The patient's current condition is reported as "fine".Please see associated mdr#'s:.,3010532612-2026-00274 & 3010532612-2026-00381.
Event or Problem Description
It was reported "difficulty passing catheter over the guidewire.Replaced the iab for another 50 cc fiberoptic sc iab.Once the iab was in place, they initiated the therapy and got a high-pressure alarm.They also had difficulty seeing the balloon fully inflate.They watched the iab for a few minutes and it seemed to be supporting the patient, but they continued to give high pressure alarms.They noted that the tip seemed to be fully inflating now.The patient was not on any vasopressors.The physician decided to replace the balloon using the same site.Replaced the balloon with a second 50 cc fiberoptic sc.They were able to get balloon placed without any difficulty.When they initiated therapy, they got high pressure alarms again.The tip was slow to fully inflate.The patient was getting support.They decided to reduce the balloon volume to 40 cc.There were no further alarms".No patient injury or consequence reported.The patient's current condition is reported as "fine".Please see associated mdr#'s: 3010532612-2026-00274 & 3010532612-2026-00381.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 50cc 8fr fiberoptix ultra (sc) 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 iabc bladder was noted withdrawn through the teflon sheath and the sheath was noted on the iabc bladder membrane.The one-way valve was teth-ered to the short driveline tubing.The exposed portion of the bladder was fully unwrapped.The supplied 50cc inflation driveline tubing was noted connected to the short driveline tubing.No bends or kinks were noted to the returned sample.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.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 iabc bladder was noted withdrawn through the teflon sheath, which indicates the iabc was not removed from the patient correctly per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage.The bladder thickness was measured at six points with measurements ranging from 0.0074in-0.0076in 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 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.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked central lumen.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.The one-way valve was connected to the short driveline tubing, and a vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was moved from the iabc bladder and towards the bifurcate without any difficulty.Upon removal of the sheath, no damage or abnormalities noted to the iabc bladder.The iabc was connected to an iabp with the supplied 50cc 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 near the iabc distal end of the bladder and was consistent with being twisted.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.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 and proximal portion of the bladder had inflated but the distal portion of the bladder would not fully unwrap and was consistent with being twisted.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.Some blood clots exited with the guidewire.An attempt to aspirate 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, after clearing blood from the central lumen during the guidewire test.A device history record (dhr) review was con-ducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint for "difficulty seeing the balloon fully inflate" is confirmed.During the in-vestigation, the distal portion of the iabc bladder was noted twisted and the bladder would not fully inflate or unwrap.Unrelated to the reported complaint, the returned iabc bladder was found withdrawn through the teflon sheath.This indicates the user did not follow the instructions for use (ifu) and could result in damage to the device.As a result, an in service has been requested to review the ifu with the customer.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 twisted bladder.The probable root cause of the complaint is manufacturing related.A non-conformance has been initiated to further investigate the issue.

• 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: 24752914
• Report Number: 3010532612-2026-00382
• Device Sequence Number: 10360208
• Product Code: DSP
• UDI-Device Identifier: 10801902218923
• UDI-Public: (01)10801902218923(11)251117(17)271031(10)18F25L0020(21)
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/03/2026

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: 18F25L0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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