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	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "a patient with acute myocardial infarction complicated with cardiogenic shock was treated with ecmo combined with iabp.In the process of insertion, the catheter was stuck in sheath, change new catheter".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(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.The sample was re-turned in a cardboard box and was in a sealed ziploc bag.Upon return, the teflon sheath was noted on the section of the iabc bladder; the exposed portion of the bladder was fully unwrapped.The one-way valve was tethered to the short driveline tubing.No bend or kink was noted to the iabc central lumen.Dried blood was noted on the exterior surfaces of the returned sample; no blood was noted within the helium pathway.No visual damage or abnormalities were noted to the iabc catheter or the teflon sheath.The bladder thickness was measured at six points with measurements ranging from 0.0061in-0.0065in and was within specification of process document.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 iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Blood exited.The one-way valve was connected to the short driveline tubing, and a vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was moved from the iabc bladder and towards the bifurcate without any difficulty.Upon removal of the sheath, no damage or abnormalities noted to the iab catheter.The section of the bladder, which was previously covered by the teflon sheath was fully wrapped.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.The returned 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.Blood was noted on the guidewire upon removal.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 that the "catheter was stuck in sheath" is not confirmed.The teflon sheath was noted on the iabc bladder upon receipt of the sample; however, the sheath was able to be moved from the iabc bladder without any difficulty during the functional testing.No damage or abnormalities were noted to the returned iab catheter or the teflon sheath.The returned intra-aortic balloon catheter (iabc) passed functional test specifications.Based on a review of the device his-tory record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.
Event or Problem Description
It was reported "a patient with acute myocardial infarction complicated with cardiogenic shock was treated with ecmo combined with iabp.In the process of insertion, the catheter was stuck in sheath, change new catheter".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: 23057534
• Report Number: 3010532612-2025-00882
• Device Sequence Number: 8617880
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)240726(17)260630(10)18F24G0131(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): 08/18/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F24G0131
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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
• Patient Sex: Unknown