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 Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "after the catheter inserted, the balloon can not inflate completely.Change the new catheter".Additional informaiton states that the second iab catheter used was inserted into a different insertion site.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) with-out the original packaging.The sample was returned in a cardboard box and was in a sealed zip-loc bag.Upon return, the super arrow-flex sheath was noted on the iabc outer lumen.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No visual damage or abnormalities were noted to the returned sam-ple.The bladder thickness was measured at six points with measurements ranging from 0.0074in-0.0079in 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.No abnormalities or debris were noted.The iabc was connected to an iabp with a lab inventory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 75mmhg backpressure was applied.The iabc was pumped for a minimum of 15 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The iabc was leak tested in accordance with testing methods from manufacturing proce-dure.No leaks were detected.Full inflation was achieved.The dev ice 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 that the "balloon cannot inflate completely" is not confirmed.The returned iabc bladder was fully intact with no abnormalities noted.During the investigation, the iabc fully inflated, and no leaks/alarms were noted.The returned device passed visual and functional test specifications.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 required at this time.
Event or Problem Description
It was reported "after the catheter inserted, the balloon can not inflate completely.Change the new catheter".Additional information states that the second iab catheter used was inserted into a different insertion site.The patient's current condition is reported as "unknown".

• 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: 23143812
• Report Number: 3010532612-2025-00943
• Device Sequence Number: 9915921
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: (01)00801902002679(11)240823(17)260731(10)18F24H0075(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): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F24H0075
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 01/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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