MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRA 8 IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06850-U
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "ruptured arrow balloon".Additional information states that the iab catheter was removed.It is unknown if the iab catheter was replaced.The patient's current condition is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "ruptured arrow balloon".Additional information states that the iab catheter was removed.It is unknown if the iab catheter was replaced.The patient's current condition is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint for "ruptured arrow balloon" is confirmed based on the customer photo provided with the complaint report.In the photo, blood was confirmed present within the helium pathway.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 during the complaint investigation due to the blood in helium pathway.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.If the product is returned at a later date, a full investigation of the sample will be completed.

• Brand Name: ARROW ULTRA 8 IAB: 8FR 50CC
• 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: 20833256
• Report Number: 3010532612-2024-01022
• Device Sequence Number: 17109437
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)240717(17)260630(10)18F24G0054(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 06/30/2026
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F24G0054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2024
• 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: CARDIOSAVES IAB PUMP CONSOLE.; CARDIOSAVES IAB PUMP CONSOLE.
• Patient Sex: Female