MAUDE Adverse Event Report: Arrow International LLC Arrow UltraFlex IAB: 7.5Fr 40cc; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06840-U
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a ziploc bag in a cardboard box.Upon return, the one-way valve was tethered and connected to the short driveline tubing.The stylet was noted inserted in the central lumen and screwed into the luer end.The sample was returned with a peel away sheath on the outer lumen.A retention tube was noted on the iabc bladder.The bladder was noted loosely wrapped.Dried blood was noted on the exterior surfaces of the returned sample.No other visual damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0063in-0.0067in and was within specification of process document.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.Upon disassembling the valve for inspection, a residue (potentially saline) was noted on the seal within the one-way valve.The one-way valve failing to pull a vacuum on the iabc bladder during device prep could cause insertion difficulty, which is consistent with the reported complaint.The seal was properly cleaned and tested again; the one-way valve 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held for at least 1 minute according to quality system document (b)(4).The stylet was unscrewed from the luer end and withdrawn from the central lumen without difficulty.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Blood exited.The iabc was leak tested in accordance with testing 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 the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.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 of catheter insertion difficulty is confirmed.During the investigation, the one-way valve was found to have an unknown residue on the sealing surface, preventing it from holding a vacuum.Failure to pull a vacuum on the iabc bladder during device preparation could cause insertion difficulty.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 leaking one-way valve.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• Brand Name: Arrow UltraFlex IAB: 7.5Fr 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: 50437707
• Report Number: 3010532612-2026-01042
• Device Sequence Number: 18482254
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: (01)00801902026804(11)241003(17)260930(10)18F24J0100
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F24J0100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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.
• Patient Age: 77 YR
• Patient Sex: Male