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

Catalog Number	IAB-05840-U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "luer lock broke off of pre-dilator".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "critical".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 8.0fr ultra intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was in a bio-hazard bag.Upon return, the teflon sheath was noted on the bladder membrane; the sheath was noted buckled.The one-way valve was tethered and connected to the short driveline tubing.The bladder was fully unwrapped.The dilator was noted damaged; the dilator hub was noted separated and no longer connected to the dilator body.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The teflon sheath was noted buckled and on the iabc bladder, which indicates the iabc was not removed correctly per the instructions for use (ifu).The instructions for use (ifu) states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), bal-loon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage.".The customer photo was reviewed.The photo shows a dilator hub was separated from the dilator body and is consistent with the reported complaint.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.No abnormalities or debris were noted.The one-way valve was connected to the short driveline tubing and a negative vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was moved towards the iabc bifurcate with little force.Upon removal, no damage was noted to the iab catheter.The iabc was leak tested in accordance with testing methods from manufacturing procedure.An external leak was immediately noted and located around the proximal end of the bifurcate bushing.No other leaks were detected.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.Some blood 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 for "luer lock broke off of pre-dilator" is confirmed.During the investiga-tion, the dilator was noted damaged and the dilator hub was noted not attached to the dilator body.Unrelated to the reported complaint, the iabc bladder was found withdrawn through the teflon sheath.This indicates the iabc was not removed per the instructions for use (ifu) and could result in damage to the device.An in service has been requested to review the instructions for use (ifu) with the customer.Based on a review of the device history record (dhr), the prod-uct met specification upon release; however, the specifications were not met during the complaint investigation due to the damaged dilator.The root cause of the complaint is undetermined.No further action is required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported "luer lock broke off of pre-dilator".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "critical".

• 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: 23838097
• Report Number: 3010532612-2025-01237
• Device Sequence Number: 9267794
• Product Code: DSP
• UDI-Device Identifier: 10801902145663
• UDI-Public: (01)10801902145663(11)241223(17)261130(10)18F24M0160(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2025

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-05840-U
• Device Lot Number: 18F24M0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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: Male