MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S730C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the catheter was inserted into the patient one hour, the pump frequent alarmed helium gas leakage.After check, it was found that there were signs of tissue fluid and blood red in the helium gas pipeline.To ensure the patient's safety, the catheter was immediately removed and a new one was inserted".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "after the catheter was inserted into the patient one hour, the pump frequent alarmed helium gas leakage.After check, it was found that there were signs of tissue fluid and blood red in the helium gas pipeline.To ensure the patient's safety, the catheter was immediately removed and a new one was inserted".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number of the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton/sealed ziploc bag.Upon return, the one-way valve was tethered to the short driveline tubing.A non-vented red end cap was noted on the iabc luer end.The iabc bladder was fully unwrapped.Spots of dried blood were noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.The sample was likely cleaned prior to its return.No visual damage or abnormalities were noted to the returned sample.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 catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked/clotted central lumen.Immediate push back on the syringe plunger was experienced.The blockage, most likely dried blood, was unable to be cleared.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.The iabc was connected to an iabp with a lab inventory 30cc inflation driveline tubing.The iabc was inserted into the "t" tube and 100mmhg 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 balloon pressure waveform (bpw) was normal.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire could not advance at approximately 11.1cm from the iabc distal tip, which is the location of the clotted central lumen.Dried blood was noted on the guidewire upon removal.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 30cm from the iabc luer, which is the location of the clotted central lumen.Dried blood was noted on the guidewire upon re-moval.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 "there were signs of tissue fluid and blood red in the helium gas pipeline" is not confirmed.No blood was noted within the iabc helium pathway upon receipt of the sample.During the investigation, the returned iab catheter was fully intact.No leaks or alarms were detected during the functional testing.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.

• Brand Name: ARROW REDIGUARD IAB: 7FR 30CC
• 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: 23254340
• Report Number: 3010532612-2025-00989
• Device Sequence Number: 21391381
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)240716(17)260630(10)18F24G0060(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): 09/11/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24G0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 12/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown