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

Catalog Number	IAB-05840-LWS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported via user report " upon unpacking the device, the optical fiber was functioning properly; however, the balloon was suspected to have been improperly wrapped.The balloon appeared tapered, pinched under the metal part, and the edges were not parallel.Decision was made not to insert the balloon for and request for an investigation from teleflex.Device was replaced with another balloon from the same reference.There were no consequences for the patient".
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 40cc 8fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a ziploc bag.Upon return, the peel away sheath was noted on the iabc.The stylet was noted inserted within the iabc central lumen.The one-way valve was tethered and connected to the short driveline.The bladder was loosely wrapped.No blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.The cal key was examined, and no damage was noted.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 returned cal key and the returned fos were connected to the iabp.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The cal key was removed and rotated 180 degrees and then reinserted with the same result.The fiber was found broken approximately 1.4cm from the iabc distal tip.The full length of the fiber was confirmed present with no other notable breaks.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.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 backpressure was applied.The iabc was pumped for a minimum of 30 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The balloon pressure waveform (bpw) was normal.The iabc was leak tested in accordance with test-ing 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 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 that "the balloon appeared tapered, pinched under the metal part, and the edges were not parallel" is not confirmed.The returned intra-aortic balloon catheter (iabc) passed visual and functional test specifications for the reported complaint.The returned iabc bladder was fully 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 via user report " upon unpacking the device, the optical fiber was functioning properly; however, the balloon was suspected to have been improperly wrapped.The balloon appeared tapered, pinched under the metal part, and the edges were not parallel.Decision was made not to insert the balloon for and request for an investigation from teleflex.Device was replaced with another balloon from the same reference.There were no consequences for the patient".

• 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: 22815617
• Report Number: 3010532612-2025-00746
• Device Sequence Number: 20262481
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: (01)00801902007247(11)240424(17)260331(10)18F24D0042(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 03/31/2026
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F24D0042
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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
• Patient Sex: Unknown