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	Insufficient Information (4580)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "during the process of preparing to remove the catheter, it was found that the catheter removal was difficult.After a long period of attempts, the catheter was finally removed from the patient's body.Upon examination, it was visually observed that there were black, unidentified solid particles gathered inside the balloon".The patient's current condition is unknown.
Event or Problem Description
It was reported "during the process of preparing to remove the catheter, it was found that the catheter removal was difficult.After a long period of attempts, the catheter was finally removed from the patient's body.Upon examination, it was visually observed that there were black, unidentified solid particles gathered inside the balloon".The patient's current condition is unknown.
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) without the original packaging box.The sample was returned in a cardboard box and was in a ziploc bag.Upon return, the teflon sheath was noted on the iabc outer lumen.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The central lumen was noted bent at approximately 12.3cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.No other damage or abnormalities were noted to the returned sample.The customer submitted photos were reviewed.In the photos, dried/liquid blood was confirmed pre-sent within the iabc bladder/helium pathway.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 docu-ment.The iabc central lumen was aspirated and flushed using a 60cc lab-inve ntory syringe.No blood or debris was noted.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, and it was tested more than once with the s ame results.A leak site was unable to be lo-cated.It could not be confidently determined what caused the blood to enter the helium pathway.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 12.3c m from the iabc distal tip, which is the location of the previously noted bend.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 "black, unidentified solid particles gathered inside the balloon" is con-firmed based on the visual inspection of the returned sample.Blood was confirmed present within the helium pathway.During the investigation, a leak site was unable to be located.It could not be confidently determined what caused the blood to enter the helium pathway.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifica-tions were not met during the complaint investigation due to the blood in the helium pathway.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.

• 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: 22903170
• Report Number: 3010532612-2025-00799
• Device Sequence Number: 8932102
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250206(17)270131(10)18F25A0093(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): 08/01/2025

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: 18F25A0093
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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