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	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported ", in the process of insertion, the catheter was stuck in sheath.The tip of the balloon was found bent after removed, change new catheter".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported ", in the process of insertion, the catheter was stuck in sheath.The tip of the balloon was found bent after removed, change 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).No lot number was reported.The lot number for the returned sample is 18f24m0046.Returned for investigation was a 40cc 8fr rediguard intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was in a ziploc bag.The one-way valve was tethered and connected to the short driveline tubing.The bladder was fully unwrapped.The sheath was not returned with the sample.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0068in-0.0072in 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 catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.Some blood and 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.No resistance was noted; the guidewire was able to advance through the central lumen.Some blood and 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 catheter was stuck in sheath" is not confirmed.The returned intra-aortic balloon catheter (iabc) passed functional test specifications.The sheath was not returned with the sample.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.

• 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: 23347108
• Report Number: 3010532612-2025-01036
• Device Sequence Number: 12700432
• 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