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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Reported as "possible iab rupture".The report further states, "[user] is calling from the ccl.They have a patient with left main disease who they have just placed a 30 cc lws iab in the r fem of a 4 ft 11 in / 69 kg f pt.Approximately20 mins after initiating therapy, they received 4 possible he loss 2 alarms.The provider is wondering if they should replace the iab.The iabp is currently paused and pt is stable.[user] confirmed there was no blood in driveline, iab position looks good on fluoroscopy, balloon is unwrapped fully, and connections are tight.We discussed other causes for this alarm.The physician opted to replace the iab at this time.He requested to connect on facetime for case support.I agreed.Upon connection, iab and sheath removed via guidewire.Another 30 cc lws iab was replaced using the r fem.After placement, we discussed occlusivity of iab.The pp was 148 and aug was 106.Physician agreeable to reduce volume to 26 cc".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
Reported as "possible iab rupture".The report further states, "[user] is calling from the ccl.They have a patient with left main disease who they have just placed a 30 cc lws iab in the r fem of a 4 ft 11 in / 69 kg f pt.Approximately 20 mins after initiating therapy, they received 4 possible he loss 2 alarms.The provider is wondering if they should replace the iab.The iabp is currently paused and pt is stable.[user] confirmed there was no blood in driveline, iab position looks good on fluoroscopy, balloon is unwrapped fully, and connections are tight.We discussed other causes for this alarm.The physician opted to replace the iab at this time.He requested to connect on facetime for case support.I agreed.Upon connection, iab and sheath removed via guidewire.Another 30 cc lws iab was replaced using the r fem.After placement, we discussed occlusivity of iab.The pp was 148 and aug was 106.Physician agreeable to reduce volume to 26 cc".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 8.0fr fiberoptix ultra (sc) intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the ups shipping box and was in a sealed bio-hazard bag.Upon return, the supplied teflon sheath was noted on the iabc outer lumen.The one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.Upon return, the fos yellow jacket cabling was cut near the iab bifurcate.The remaining length of the fos yellow jacket cabling including the fos sc connector was not returned with the sample.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 connection was unable to be tested due to the cut fos cabling.Upon checking the remaining length of the fos fiber, no visual fiber break was noted.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 manufacturing procedure.An external leak was immediately detected from the distal end of the bifurcate bushing.Under microscopic inspection, the leak from the bifurcate bushing occurred from the adhesive bond.No other leaks were detected.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.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 "possible he loss 2 alarms" is confirmed.During the complaint investigation, an external helium leak was confirmed from the intra-aortic balloon catheter (iabc) bi-furcate bushing adhesive, which resulted in the helium loss alarms.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 external leak from the iabc bifurcate bushing adhesive.The probable root cause is manufacturing related.A corrective and preventive action (capa) has been initiated to address the issue.

• 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: 24096398
• Report Number: 3010532612-2026-00098
• Device Sequence Number: 21414641
• Product Code: DSP
• UDI-Device Identifier: 10801902218909
• UDI-Public: (01)10801902218909(11)251016(17)270930(10)18F25K0035(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAB-05830-LWS-SC
• Device Lot Number: 18F25K0035
• 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: 12/21/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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