MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S850C
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "blood in helium tubing".Additional infomation states that the iab catheter was removed and it is unknown if it was replaced.The customer has not provided additional information related to this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "blood in helium tubing".Additional infomation states that the iab catheter was removed and it is unknown if it was replaced.The customer has not provided additional information related to this event.
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 50cc 8.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the ups shipping box and was in bio-hazard bag.Upon return, the teflon sheath was noted on the iabc.The one-way valve was tethered to the short driveline tubing.The supplied 50cc inflation driveline tubing was connected to the short driveline tub-ing; dried blood was noted within the inflation driveline tubing.The short arterial pressure tubing was noted connected to the iabc luer.The bladder was fully unwrapped.The central lumen was noted broken at approximately 30cm from the iabc distal tip.Multiple kinks to the iabc central lumen were noted at approximately 39.7cm, 49cm, 60.2cm, 70.2cm and 75.8cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried 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.An attempt to as-pirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation which is consistent with the previously confirmed broken central lumen.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; no other leaks were noted.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire exited the central lumen at the location of the previously confirmed broken central lumen.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 8.8cm, 14.4cm, 24.2cm, 35.6cm and 44.7cm from the iabc luer, which are the locations of the previously noted kinks.Then the guidewire exited the central lumen at the location of the previously confirmed broken central lumen.Some blood was noted on the guidewire.A device history record (dhr) review was conducted for the reported lot number.The device passed all manufacturing specifications prior to release.The reported complaint for "blood in helium tubing" is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken, which allowed blood to enter the helium pathway.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 broken central lumen.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: ARROW REDIGUARD IAB: 8FR 50CC
• 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: 23347167
• Report Number: 3010532612-2025-01043
• Device Sequence Number: 9451926
• Product Code: DSP
• UDI-Device Identifier: 10801902144208
• UDI-Public: (01)10801902144208(11)250220(17)270131(10)18F25B0088(21)
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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-S850C
• Device Lot Number: 18F25B0088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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
• Patient Sex: Unknown