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	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "delayed unwrapping and side port difficulty".The report further states that there was sheath difficulty noted upon prep.The issue was resolved by using another sheath in the kit and the iab eventually unwrapped.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The reported complaint for "delayed unwrapping " 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "delayed unwrapping and side port difficulty".The report further states that there was sheath difficulty noted upon prep.The issue was resolved by using another sheath in the kit and the iab eventually unwrapped.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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24097143
• Report Number: 3010532612-2026-00011
• Device Sequence Number: 10397374
• Product Code: DSP
• UDI-Device Identifier: 10801902145663
• UDI-Public: (01)10801902145663(11)250822(17)270731(10)18F25H0064(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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 Catalogue Number: IAB-S840C
• Device Lot Number: 18F25H0064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown