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

Model Number	IPN917533
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported " the perfusionist reported an iab rediguard which did not fully inflated the balloon and therefor gave alarms and no sufficient cardiac support.Cardiologist placed the iab and after they started the iabp the balloon did not function as mentioned.They removed this iab and placed a second rediguard, who functioned perfectly.No further harm was done to the patient".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).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 re-turned in a cardboard box and was loosely packed within the original packaging carton.Returned with the sample was supplied data-scope 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 iabc bladder was noted fully unwrapped.Furthermore, the iabc bladder was noted enlarged/stretched near the proximal end of the bladder.No blood was noted on the interi-or or the exterior surfaces of the returned sample.The sample was likely cleaned prior to the return.The bladder thickness was measured at six points, where the bladder was not enlarged/stretched, with measurements ranging from 0.0067in-0.0069in and was within specification of process docu-ment.The bladder thickness was measured at several points, where the bladder was noted enlarged/ stretched, with measurements ranging from 0.0039in-0.0050in and was not 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.The iabc central lu-men was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was connected to an iabp with a lab inventory 40cc inflation driveline tubing.The iabc was inserted into the "t" tube and 75mmhg backpressure was applied.The pumping was initiated.The iabc bladder showed incomplete inflation near its distal end, consistent with an enlarged/stretched bladder.This structural enlargement near the proximal end of the bladder impedes effective helium delivery to the distal section of the bladder, resulting in incomplete inflation.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detected.During the leak test, the proximal end of bladder was noted enlarged.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guide-wire 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 "iab rediguard which did not fully inflated the balloon" is confirmed.Upon return, the proximal end of the iab balloon was noted damaged and was consistent with being enlarged/ stretched.During the investigation, the distal section of the bladder did not fully inflate.The enlarged/ stretched bladder near the proximal end impedes effective helium delivery to the distal section of the bladder, resulting in incomplete inflation.The iabc bladder was fully intact, and no leaks were detected.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 enlarged bladder.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported " the perfusionist reported an iab rediguard which did not fully inflated the balloon and therefor gave alarms and no sufficient cardiac support.Cardiologist placed the iab and after they started the iabp the balloon did not function as mentioned.They removed this iab and placed a second rediguard, who functioned perfectly.No further harm was done to the patient".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: 22700662
• Report Number: 3010532612-2025-00716
• Device Sequence Number: 15689524
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)240124(17)251231(10)18F24A0026(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: IPN917533
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24A0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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 Age: 70 YR
• Patient Sex: Female