MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06830-U
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the catheter insertion process in the hospital's interventional room for a patient, it was found that the blood in helium pathway.Change the new catheter and the procedure continued normally." no patient injury or consequence reported.The patient's current condition 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 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number for the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Upon return, the peel away sheath was on the iabc.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the central lumen was noted at approximately 24cm from the distal tip.No blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium path-way; the catheter was likely cleaned prior to return.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 catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested in accordance with t esting meth-ods 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.The guidewire met resistance and could not advance at approximately 24cm from the iabc distal tip; which is the location of the previously noted bend.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approxi-mately 74cm from the iabc luer; which is the location of the previously noted bend.No blood or de-bris was noted on the guidewire.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 helium pathway" is not confirmed.During the investigation, no damage or abnormalities were noted to the returned sample.The returned device passed visual and functional test specifications.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 "after the catheter insertion process in the hospital's interventional room for a patient, it was found that the blood in helium pathway.Change the new catheter and the procedure continued normally." no patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 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: 23525890
• Report Number: 3010532612-2025-01089
• Device Sequence Number: 9021608
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250116(17)261231(10)18F25A0029(21)
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Catalogue Number: IAB-06830-U
• Device Lot Number: 18F25A0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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
• Patient Sex: Unknown