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	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported ", after the catheter inserted, the pump alarmed balloon high-pressure alarm.The balloon was found that can not inflate completely after remove the catheter.Change the new catheter." no patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(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 tray/carton.Upon return, the one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.No blood was noted on the interior or the exterior surfaces of the returned sample.No visual damage or abnormalities were noted to the returned sample.The sample likely cleaned prior to the return.The customer submitted photo was reviewed.In the photo, the proximal end of the bladder was found to be not fully inflating, which is consistent with the reported event.The bladder thickness was measured at six points with meas-urements ranging from 0.0066in-0.0069in 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.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 connected to an iabp with a lab invento-ry 30cc inflation driveline tubing.The iabc was inserted into the "t" tube and 75mmhg backpressure was applied.The iabc was pumped for a minimum of 15 minutes.There were no alarms trig-gered.The bladder inflated and deflated completely with each beat.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 the iabc distal tip.The guidewire could not advance at approximately 11.2cm 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 ad-vance at approximately 41.4cm from the iabc luer, which is the location of the clotted central lumen.Dried blood was noted on the guidewire upon removal.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 of "balloon was found that cannot inflate completely" is confirmed based on the customer provided photo with the complaint report.In the photo, the proximal end of the bladder was found to be not fully inflating; however, during the investigation, the returned iabc bladder was fully intact with no abnormalities noted.The iabc fully inflated, and no leaks or alarms were detected.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.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported ", after the catheter inserted, the pump alarmed balloon high-pressure alarm.The balloon was found that can not inflate completely after remove the catheter.Change the new catheter." 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: 23511313
• Report Number: 3010532612-2025-01083
• Device Sequence Number: 18630650
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)240625(17)260531(10)18F24E0116(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,Distributor
• 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 Expiration Date: 05/31/2026
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24E0116
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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
• Patient Sex: Unknown