MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S840C
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported ", the catheter can't be inserted into the patient".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".
Event or Problem Description
It was reported ", the catheter can't be inserted into the patient".Additional information states the iab catheter was removed and replaced.No patient injury or consequence reproted.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint that the "catheter can't inserted into the patient" 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 catheter can't be inserted into the patient".Additional information states the iab catheter was removed and replaced.No patient injury or consequence reproted.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 40cc 8.0fr 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.Upon return, the peel away sheath was noted on the returned sample.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.No visible bends or kinks were noted to the iabc central lumen.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the heli-um pathway.No visual damage or abnormalities were noted to the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0072in-0.0078in 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 the quali ty system docu-ment.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No ab-normalities or debris were noted.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.No re-sistance was noted; the guidewire was able to advance through the central lumen.No blood or de-bris 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 "catheter can't inserted into the patient" is not able to be confirmed.During the investigation, no visual damage or abnormalities were noted to the returned sample.The returned iabc passed functional testing.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 fur-ther action required at this time.

• Brand Name: ARROW REDIGUARD IAB: 8FR 40CC
• 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: 22807362
• Report Number: 3010532612-2025-00747
• Device Sequence Number: 13001987
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: (01)00801902002679(11)241113(17)261031(10)18F24L0033(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): 07/18/2025

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 Catalogue Number: IAB-S840C
• Device Lot Number: 18F24L0033
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 11/07/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/15/2025; 12/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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