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

Catalog Number	IAB-S840C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "after opening the package, the catheter had already expanded and could not be used to create negative pressure for retraction, and it was impossible to insert it into the puncture sheath.It was suspected that the catheter had been damaged.A new catheter was replaced and the operation was continued".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after opening the package, the catheter had already expanded and could not be used to create negative pressure for retraction, and it was impossible to insert it into the puncture sheath.It was suspected that the catheter had been damaged.A new catheter was replaced and the operation was continued".No patient injuryu or consequence reported.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 serial number of the returned sample.The sample was returned within a cardboard box and was loosely packed within the original packaging tray/ sealed ziploc bag.Upon return, the origi-nal packaging tray was immediately noted with damage to the "arrow" packaging sticker.The iabc bladder was noted reinserted within the packaging retention sleeves.The visible portion of the bladder was noted fully unwrapped.The peel away sheath was noted on the iabc outer lu-men.The one-way valve was tethered to the short driveline tubing.No blood was noted on the interior or the exterior surfaces of the returned sample.The original packaging tray was noted with damage to the "arrow" packaging sticker.The arrow sticker was noted cut/ripped.This packaging sticker is not to be removed.This condition indicate a potential that the catheter was not prepped per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states:"1.Connect one-way valve to male luer on short driveline tubing attached to iab.Insert su pplied sy-ringe into one-way valve.Slowly aspirate a full syringe of air.Precaution: the one-way valve will maintain vacuum on the balloon and must remain in place until is fully inserted.Remove syringe.2.Remove catheter from tray, keeping it in line with balloon membrane.3.Grasp catheter close to tray and pull it straight out of the holding sleeve.Note: keep catheter level with tray.Do not lift or bend during removal.The bladder thickness was measured at six points with measurements ranging from 0.0076in-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 quality system document.The on-way valve was connected to the short driveline tubing, and a negative vacuum was pulled on the returned iabc.While maintaining the vacuum, the iabc bladder was removed from the packaging retention sleeve without any difficul-ty.Upon removal, no other damage or abnormalities were noted to the bladder.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 procedure.A leak was immediately detected from the bladder membrane.Under microscopic in-spection, the leak site is consistent with contact from a sharp object and was noted approxi-mately 1.3cm 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 "catheter had already expanded" is confirmed.During the inves-tigation, a puncture consistent with contact from a sharp object, was found the on the iabc bladder.A punctured bladder will result in difficulty of maintaining a vacuum on the iabc blad-der.If a vacuum on the bladder is not maintained, it can result in a bladder to unwrap premature-ly.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker.This indicates the user did not follow the instructions for use (ifu) and could result in damage to the device.As a result, an in-service for the customer is requested to reiterate the ap-propriate method for iab prep/removal from its packaging.Based on a review of the device histo-ry 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 cus-tomer handling related.This will be monitored for any developing trends.

• 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: 23257567
• Report Number: 3010532612-2025-00974
• Device Sequence Number: 20075282
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: (01)00801902002679(11)240320(17)260228(10)18F24C0073(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
• Report Date (Section B): 09/12/2025

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: 02/28/2026
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F24C0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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