MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S840C
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "in the interventional operating room of the hospital, during the catheter inserted into the patient, the tip of the balloon was bent.After multiple attempts to place it, it still could not be positioned properly.Change the new 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)(6).Returned for investigation was a 40cc 8fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the se-rial number for the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Returned with the sample was two (2) 0.025in guide-wires, a teflon sheath, and a 30cc inflation driveline tubing.Upon return, the peel away sheath was on the iabc.The one way valve was tethered and connected to the short driveline tubing.The blad-der was fully unwrapped.The outer lumen was noted bent at approximately 69.9cm from the distal tip.The central lumen was noted kinked at approximately 0.7cm from the distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the 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 document.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory 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.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.Resistance was noted at approximately 0.7cm; which is the location of the previously noted kink.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 "the tip of the balloon was bent" is confirmed.A kink to the central lumen was noted during the visual inspection of the returned iab catheter, and resistance was noted at the location of the kink upon loading a guidewire into the iabc central lumen.Based on a review of the device history record (dhr), the product met specification upon release; however, specifications were not met during the complaint investigation due to the kinked central lumen.The root cause of the kink is undetermined, but a potential cause is customer handling.No further action is required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "in the interventional operating room of the hospital, during the catheter inserted into the patient, the tip of the balloon was bent.After multiple attempts to place it, it still could not be positioned properly.Change the new catheter".No patient injury or consequence reported.The patient's current condition is reported as "fine".

• Brand Name: ARROW REDIGUARD IAB: 8FR 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: 23347073
• Report Number: 3010532612-2025-01033
• Device Sequence Number: 7770928
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: (01)00801902002679(11)241216(17)261130(10)18F24M0046(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981660
• 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): 09/25/2025

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-S840C
• Device Lot Number: 18F24M0046
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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