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	10/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "after the catheter into the patient, the blood was found in helium pathway.After the catheter was removed, it was found that the front end of the balloon was bent".Additional information states that the same insertion site was used for the second iab catheter.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the catheter into the patient, the blood was found in helium pathway.After the catheter was removed, it was found that the front end of the balloon was bent".Additional information states that the same insertion site was used for the second iab catheter.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)(4).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 one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the central lumen was noted approximately 41cm from the iabc distal tip.The central lumen was noted broken at approximately 5.1cm from the iab distal tip.No blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway; the catheter was likely cleaned prior to re-turn.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.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation, which is consistent with the previously confirmed broken central lumen.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire exited the central lumen and entered the bladder at the location of the broken central lumen.Some blood and debris was noted.The guidewire was front loaded through the iabc luer.No resistance was noted; the guidewire exited the central lumen and entered the bladder at the location of the broken central lumen.Some blood and 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 was found in helium pathway" is confirmed.During the investiga-tion, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc distal tip, which allowed blood to enter the helium pathway.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 broken central lumen.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 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: 23644565
• Report Number: 3010532612-2025-01172
• Device Sequence Number: 9858948
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250429(17)270331(10)18F25D0077(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-06830-U
• Device Lot Number: 18F25D0077
• 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: 12/23/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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