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

Catalog Number	IAB-S730C
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " the nurse noticed an abnormal blood pressure waveform on the iabp display screen.Upon inspection, it was found that there was bleeding at the connection of the y-shaped connection.The patient's condition was stable, so the doctor removed the catheter.The patient was in good condition".Additional infomation states that the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).No serial number was reported.Upon return the serial number label was damaged and the full serial number of the returned iabc is illegible.The lot number reported is 18f24k0130.The lot number of the returned device is suspected to be from the reported lot; however, no original packaging/label was returned.Returned for investigation was a 30cc 7fr 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.Upon return, the super arrow flex (saf) sheath was noted on the iabc.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Upon further investigation, a crack was noted on the iabc bifurcate luer.Dried blood was noted on the exterior sur-faces of the returned sample.No obvious blood was noted within the helium pathway.The customer photo and video were reviewed.The photo and video show blood leaking from the iab bifurcate.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 was unable to aspirated and flushed successfully due to the crack on the iabc luer end.The iabc was leak tested using in ac-cordance 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 specifica-tions prior to release.The reported complaint for "bleeding at the connection of the y-shaped connection" is confirmed.During the investigation, a crack was found at the injection site of the iabc bifurcate for the central lumen, which caused the reported complaint.This crack could allow a leak to occur at the injection site of the central lumen.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 investiga-tion due to the crack found on the bifurcate.The root cause of the complaint is undetermined.This will be monitored for any developing trends.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported " the nurse noticed an abnormal blood pressure waveform on the iabp display screen.Upon inspection, it was found that there was bleeding at the connection of the y-shaped connection.The patient's condition was stable, so the doctor removed the catheter.The patient was in good condition".Additional infomation states that the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• 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: 23478496
• Report Number: 3010532612-2025-01081
• Device Sequence Number: 10202932
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)241025(17)261031(10)18F24K0130(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): 10/13/2025

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-S730C
• Device Lot Number: 18F24K0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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