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	06/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the interface of the helium gas pipeline of the catheter is leaking".Additional information states the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "interface of the helium gas pipeline of the catheter is leaking" is not able to be confirmed.The product was not returned for investigation.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.If the product is returned at a later date, a full investigation of the sample will be completed.
Event or Problem Description
It was reported "the interface of the helium gas pipeline of the catheter is leaking".Additional information states the iab catheter was removed and replaced.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) with the original packaging box that matches the se-rial 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.Returned with the sample was sup-plied 30cc inflation driveline tubing; no damage or abnormalities were noted to the returned inflation driveline tubing.Upon return, the one-way valve was tethered to the short driveline tubing.The blad-der was fully unwrapped.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.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 the 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 manufacturing pro-cedure.A leak was immediately detected from the iabc outer lumen.The leak site was consistent with contact from a sharp object, and it was noted on the iabc outer lumen approximately 57.3cm from the iabc distal tip.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.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 the "helium gas pipeline of the catheter is leaking" is confirmed.During the investigation, the iab catheter was confirmed with a leak from the outer lumen, which caused the reported complaint.The outer lumen leak site identified was consistent with contact from a sharp object.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 investigation due to the leak from the outer lumen.The probable root cause of the outer lumen leak is customer handling related.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "the interface of the helium gas pipeline of the catheter is leaking".Additional information states the iab catheter was removed and replaced.No patient injury or cosnequence 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: 22775837
• Report Number: 3010532612-2025-00732
• Device Sequence Number: 9167442
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)240930(17)260831(10)18F24J0127(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): 07/15/2025

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: 08/31/2026
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24J0127
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 11/07/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/09/2025; 12/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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