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

Catalog Number	IAB-S730C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn(b)(4).
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 7 days of treatment, the pump alarm helium leakage and an excessively high baseline.A syringe was used to withdraw gas from the helium pipeline.No blood or tissue fluid was found.To ensure the patient's safety, the catheter was removed and a new catheter was inserted.The balloon was found to have signs of bending".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 7 days of treatment, the pump alarm helium leakage and an excessively high baseline.A syringe was used to withdraw gas from the helium pipeline.No blood or tissue fluid was found.To ensure the patient's safety, the catheter was removed and a new catheter was inserted.The balloon was found to have signs of bending".No patient injury or consequence reported.The patient's current condition is reported as "fine".
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) without the original packaging.The sample was re-turned in a cardboard box and was in a sealed 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.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No visual damage or abnormalities were not-ed 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.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufactur-ing 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 complete-ly with each beat.The balloon pressure waveform (bpw) was normal.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.No blood or debris 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 that "gas was withdrawn from the helium pipeline and blood was found" is not confirmed.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.
Event or Problem Description
It was reported "the catheter was inserted into the patient.After 7 days of treatment, the pump alarm helium leakage and an excessively high baseline.A syringe was used to withdraw gas from the helium pipeline.No blood or tissue fluid was found.To ensure the patient's safety, the catheter was removed and a new catheter was inserted.The balloon was found to have signs of bending".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: 22575286
• Report Number: 3010532612-2025-00669
• Device Sequence Number: 9700346
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)240626(17)260531(10)18F24E0112(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,Followup
• Report Date (Section B): 06/26/2025

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: 18F24E0112
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 11/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/21/2025; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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