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

Catalog Number	IAB-05840-LWS-SC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "andnoticed blood backing up at the catheter's central lumen connection in the teleflex pressure tubing attachment(the short one with stopcock), but then noted that tubing was cracked and was separating at distal attachmentand leaking blood.[user] stated "someone may have used a kelly clamp on it," but other staff reporting tubing "easily separated on its own".Additional informaiton states to continue therapy the "pressure tubing connected directly to the central lumen".The patients current condition is unknown.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint that the "tubing was cracked" is confirmed based on the submitted photo.The product was not returned for investigation.The photo shows a broken luer end of the arterial pressure tubing.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 broken luer of the ap tubing.The root cause of the complaint is undetermined.A potential cause is user related, where the ap connection is overtightened.No further action is required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "andnoticed blood backing up at the catheter's central lumen connection in the teleflex pressure tubing attachment (the short one with stopcock), but then noted that tubing was cracked and was separating at distal "attachment and" leaking blood.[user] stated, "someone may have used a kelly clamp on it," but other staff reporting tubing "easily separated on its own".Additional "information" states to continue therapy the "pressure tubing connected directly to the central lumen".The patients current condition is unknown.

• 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: 22345202
• Report Number: 3010532612-2025-00587
• Device Sequence Number: 8573255
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: (01)00801902007247(11)250218(17)270131(10)18F25B0040(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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 Catalogue Number: IAB-05840-LWS-SC
• Device Lot Number: 18F25B0040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2025
• 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
• Patient Sex: Unknown