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	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the catheter inserted into the patient successful.After about 3 minutes the pump alarmed the balloon pressure high, and the counterpulsation was suspended.Later, it was discovered that there was blood leakage, so the catheter was removed.Change the new catheter".No patient's injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported " the catheter inserted into the patient successful.After about 3 minutes the pump alarmed the balloon pressure high, and the counterpulsation was suspended.Later, it was discovered that there was blood leakage, so the catheter was removed.Change the new catheter".No patient's injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed ziploc bag.Upon return, the teflon sheath was noted on the iabc outer lumen.The one-way valve was connected and tethered to the short driveline tubing.The iabc bladder was fully unwrapped.The iabc central/outer lumen was noted bent at approximately 27.8cm from the iabc distal tip.No blood was noted on the exterior surfaces of the returned sample; the sample was likely cleaned externally prior to its return.A small amount of dried blood was noted within the bladder/helium pathway.No other visual damage or abnormalities were noted to the returned 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 the quality system document.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.A leak was immediately detected from the outer lumen near the proximal end of the iabc bladder at approximately 31.7cm from the iabc distal tip.The leak sites were unable to be located under the microscopic inspection.The cause of the leak could not be confidently determined.No leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 27.7cm 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 "blood leakage" is confirmed.During the investigation, the iabc was confirmed with leak from the outer lumen near the proximal end of the bladder, which allowed blood to enter the helium pathway.The cause of the damaged outer lumen could not be confidently determined.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 outer lumen leak.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• 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: 23644437
• Report Number: 3010532612-2025-01171
• Device Sequence Number: 9646495
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: (01)00801902026804(11)241104(17)261031(10)18F24K0121(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): 10/29/2025

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-06840-U
• Device Lot Number: 18F24K0121
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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.; N/A.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 65 KG