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

Catalog Number	IAB-05840-LWS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The report states "failed leak test- potential rupture".The report further states that "patient was having multiple helium loss 2 alarms x9, from 605 to 650, prior to being connected.[user] checked all connections, they were tight and secure, the patient had a 40cc ec iabc (gs40886).Waveforms appropriate upon connection, 2 more alarms went off when connected, both helium loss 2.Decided to do a leak test, this indicated a potential issue on the catheter end.Discussed with [the user] this could be a potential rupture and to contact her providers to discuss removal and/or replacement depending on their plan of care".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "failed leak test - potential rupture" 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 c omplaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states "failed leak test- potential rupture".The report further states that "patient was having multiple helium loss 2 alarms x9, from 605 to 650, prior to being connected.[user] checked all connections, they were tight and secure, the patient had a 40cc ec iabc (gs40886).Waveforms appropriate upon connection, 2 more alarms went off when connected, both helium loss 2.Decided to do a leak test, this indicated a potential issue on the catheter end.Discussed with [the user] this could be a potential rupture and to contact her providers to discuss removal and/or replacement depending on their plan of care".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ARROW FIBEROPTIX ULTRA 8 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: 23407479
• Report Number: 3010532612-2025-01054
• Device Sequence Number: 9066875
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: (01)00801902007247(11)240718(17)260630(10)18F24G0045(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• 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): 10/01/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F24G0045
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown