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

Catalog Number	IAB-S840C
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No serial number was reported.The serial number on the returned sample is (b)(6).The lot number (18f25k0046) recorded on the complaint report matches the lot number on the returned original packaging box and for the returned sample.Returned for investigation was a 40cc 8fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number of 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 connected and tethered to the short driveline tubing.The bladder was fully unwrapped.No 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 noted to the returned sample.The sample was likely cleaned prior to its return.The customer submitted photos that were reviewed.The photo shows the original packaging carton label with the serial number and lot number information, which matches the serial number and lot number for the returned sample.The photos show the iabc in question within the clear plastic bag.The reported complaint cannot be confirmed from the review of the customer provided photos.The bladder thickness was measured at six points with measurements ranging from 0.0072in-0.0073in 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 quality system document.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.Corrective action is not required.The reported complaint that the "balloon did not fully inflate" is not confirmed.During the investigation, the returned iabc bladder was fully intact with no abnormalities noted.The iabc fully inflated, and no leaks or alarms were detected.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.The reported complaint will be monitored for any developing trends.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "after insertion, the wave-form signal was incorrect.Upon checking the imaging, it was found that the balloon did not fully inflate (fully open).Later, even with manual handling, it still could not be opened".As a result the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25086193
• Report Number: 3010532612-2026-00424
• Device Sequence Number: 10409194
• Product Code: DSP
• UDI-Device Identifier: 10801902145663
• UDI-Public: (01)10801902145663(11)251013(17)270930(10)18F25K0046(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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 Catalogue Number: IAB-S840C
• Device Lot Number: 18F25K0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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