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

Catalog Number	IAB-05840-LWS-SC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported complaint for "severely kinked he driveline causing he related alarms" is confirmed based on the customer provided photos with the complaint report.In the photos, the inflation driveline tubing was noted kinked.The kinked inflation driveline tubing can impede or prevent the helium supply and can cause helium loss alarm.Based on the event details, the issue was resolved after replacing the inflation driveline tubing.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the kinked inflation driveline tubing.The root cause of the kinked inflation driveline tubing is undetermined; a potential root cause is customer handling related.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported that "caller reports possible he loss 3 and high baseline alarms.Helium driveline found to be severely kinked.Caller has retrieved another helium driveline.Helium driveline exchanged successfully.He alarms resolved after exchange".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB SC: 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: 25206072
• Report Number: 3010532612-2026-00560
• Device Sequence Number: 21073660
• Product Code: DSP
• UDI-Device Identifier: 10801902218916
• UDI-Public: (01)10801902218916(11)251108(17)271031(10)18F25K0097(21)
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K993966
• 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
• Report Date (Section B): 05/11/2026

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-05840-LWS-SC
• Device Lot Number: 18F25K0097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2025
• 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.
• Patient Age: 77 YR
• Patient Sex: Male