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

Catalog Number	IAB-S840C
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " after the catheter inserted into the patient, the balloon could not inflate completely.An emergency method was attempted: inflating the balloon with a syringe.However, there was significant resistance, and dsa imaging showed that the balloon still could not be inflate.Subsequently, the catheter was replaced with new one".No patient injury or cosnequence 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 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a ziploc bag.Upon return, the supplied 40cc driveline inflation tubing was noted connected to the short driveline tubing.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The central/outer lumen was kinked at approximately 35.1cm from the distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the bladder/helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0056in-0.0063in 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.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked/clotted central lumen.Upon aspiration, water was unable to be pulled into the syringe.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.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.The guidewire met resistance and could not advance at approximately 29cm from the iabc distal tip.Some blood and debris was noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 24cm from the iabc luer.Some blood and debris was noted on the guidewire.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 "balloon could not inflate completely" is not confirmed.The returned intra-aortic balloon catheter (iabc) passed functional test specifications.The returned iabc bladder was fully intact with no abnormalities noted.During the investigation, the iabc fully inflated, and no leaks were detected.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action is required at this time.
Event or Problem Description
It was reported "after the catheter inserted into the patient, the balloon could not inflate completely.An emergency method was attempted: inflating the balloon with a syringe.However, there was significant resistance, and dsa imaging showed that the balloon still could not be inflate.Subsequently, the catheter was replaced with new one".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: 24020382
• Report Number: 3010532612-2026-00041
• Device Sequence Number: 12996687
• Product Code: DSP
• UDI-Device Identifier: 10801902145663
• UDI-Public: (01)10801902145663(11)250224(17)270131(10)18F25B0095(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): 12/16/2025

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: 18F25B0095
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown