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

Catalog Number	IAB-S730C
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "after 2 hours of treatment, the pump alarm helium leakage.Gas was withdrawn from the helium pipeline and blood was found.Therefore, a new catheter was immediately replaced".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "after 2 hours of treatment, the pump alarm helium leakage.Gas was withdrawn from the helium pipeline and blood was found.Therefore, a new catheter was immediately replaced".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint that "blood was found" 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 is 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It was reported "after 2 hours of treatment, the pump alarm helium leakage.Gas was withdrawn from the helium pipeline and blood was found.Therefore, a new catheter was immediately replaced".No patient injury or consequence reported.The patient's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 7fr rediguard intraaortic balloon catheter (iabc) with the original packaging box that matches the serial number for the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging carton.Upon return, 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.Some dried blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0061in-0.0067in and was within specification of process document.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.Dried blood was noted within the one-way valve.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked central lumen.Upon aspiration, water was unable to be pulled into the syringe.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc bladder membrane at approximately 13.5cm from the distal tip.The leak site was consistent with contact from a sharp object; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.The guidewire met resistance and could not advance at approximately 24.4cm from the iabc distal tip.Some blood and debris was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 43cm from the iabc luer.Some blood and debris was noted on the guidewire.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 for "gas was withdrawn from the helium pipeline and blood was found" is confirmed.During the investigation, a puncture consistent with contact from a sharp object was found on the iabc bladder and this caused the reported complaint.No other leaks were detected during functional testing.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 bladder leak.The probable root cause is customer handling related.No further action is required at this time.This will be monitored for any developing trends.

• 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: 22566626
• Report Number: 3010532612-2025-00662
• Device Sequence Number: 21152977
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: (01)00801902002686(11)241023(17)260930(10)18F24K0073(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): 06/25/2025

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: 09/30/2026
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24K0073
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 10/21/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/18/2025; 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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