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

Catalog Number	IAB-S840C
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " , an iabc implantation was performed.During the implantation process, the catheter was difficult to insert and could not be implanted.Change the new catheter".Additional information states that the iab was removed and replaced.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 sample is (b)(6).The lot number: (18f24j0021) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number of the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton/sealed ziploc bag.Upon return, the one-way valve was noted tethered to the short driveline tubing.The iabc bladder was fully unwrapped.Multi-ple kinks to the iabc central lumen were noted at approximately 8.5cm, 11.9cm, 12.4cm, 12.8cm, 13.7cm, 14.1cm, 14.5cm, 15.6cm, 16.5cm, 17cm, 17.6cm, 18.5cm, 19.2cm, 20.1cm, 32.4cm, 69.6cm and 75.8cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.No other visual damage or abnormalities were noted to the returned sample.The one-way valve was tested and passed.A vacuum w as pulled on the one-way valve, and it held for at least 1 minute according to quality system docu-ment.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Blood exited.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 the iabc distal tip.Resistance was noted at approximately 8.5cm, 12cm, 12.5cm, 12.9cm, 14.2cm, 14.4cm, 15.8cm, 16.6cm, 17.1cm, 17.8cm, 18.5cm, 19.3cm, 20.3cm, 32.4cm, 69.5cm and 75.8cm from the iabc distal tip, which are the locations of the previously noted kinks.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 difficult to insert and could not be implanted" is confirmed.The intra-aortic balloon catheter (iabc) was returned with multiple kinks to the central lumen.The kinked central lumen can result in difficulty inserting the iabc into the patient.The iabc bladder was fully intact with no damage noted.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 kinked central lumen.The root cause of the kinked central lumen is undetermined; a potential root cause is customer handling related.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported ", an iabc implantation was performed.During the implantation process, the catheter was difficult to insert and could not be implanted.Change the new catheter".Additional information states that the iab was removed and replaced.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: 23525702
• Report Number: 3010532612-2025-01087
• Device Sequence Number: 18413064
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: (01)00801902002679(11)240918(17)260831(10)18F24J0021(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): 10/15/2025

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: 08/31/2026
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F24J0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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 Sex: Unknown