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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the doctor found the sheath damaged during insertion".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The serial number on the returned iab catheter is ak50573.Returned for investigation was an 8.0fr teflon sheath with dilator assembly, 8.0fr dilator, and a pre-dilator from a semi-finished in-sertion kit for a 30cc ultraflex intra-aortic balloon catheter (iabc).The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Returned with the sample was supplied semi-finished kit; the returned semi-finished kit appeared completely sealed and unused.Upon return, one of the dilators was noted to be fully inserted within its cor-responding teflon sheath.The dilator was removed from its corresponding teflon sheath without any difficulty.The hub of each dilator and pre-dilator appeared typical.Upon further inspection, the tip of each dilator, including the pre-dilator, was found to be damaged/split; the appearance of each dilator tip, including the pre-dilator tip, showed an inconsistent diameter with damage to the material at the tip opening.Some dried blood was noted on the exterior surfaces of the re-turned sample.No blood was noted within the interior surfaces of the returned sample.No other damage or abnormalities were noted.The tip and hub of the teflon sheath appeared typical.Some dried blood was noted on the exterior surfaces of the teflon sheath.No damage or abnor-malities were noted.Each returned dilator, pre-dilator and the teflon sheath was aspirated and flushed successfully.No abnormalities or debris were noted.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 one-way valve was connected to the short driveline tubing, and a negative vacuum was pulled on the iabc catheter.While maintaining the vacuum, the iab catheter was removed from the original packaging tray without any difficulty.Upon removal, the iabc bladder was fully wrapped.The stylet was removed from the iabc central lumen without any difficulty.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory sy-ringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with test-ing methods 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 the iabc distal tip.No resistance was noted; 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 of dilator tip damaged is confirmed.During the investigation, each returned dilator including the pre-dilator was found to be damaged/split at the tip.The appearance of each dilator tip, including the pre-dilator tip, showed an inconsistent diameter with damage to the material at the tip opening.The cause of the damage is undetermined.No damage or abnor-malities were noted to the returned teflon sheath.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 damaged dilator tip.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "the doctor found the sheath damaged during insertion".Additional information states that the iab catheter was removed and replaced.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: 24052609
• Report Number: 3010532612-2026-00057
• Device Sequence Number: 9707017
• Product Code: DSP
• UDI-Device Identifier: 10801902145625
• UDI-Public: (01)10801902145625(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): 12/19/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/10/2026
• 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