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	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "high pressure alarms, iab rupture".Additional information states the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "high pressure alarms, iab rupture".Additional information states the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer submitted seven photos for analysis; the first six pictures show the alarm history on the intra-aortic balloon pump (iabp) screen.The history shows various alarms including high pres-sure, pump off longer than 3 min, ecg lead fault, ap cal data was not read, ap fos signal weak, no ecg signal available, system running on battery power, no ap signal available, trigger loss, and insufficient time to deflate.The seventh image shows the juncture hub of an intra aortic balloon catheter (iabc).The serial number printed on the hub matches the reported serial number.Blood is visible within the clamped helium pathway.The central lumen is capped off.No other defect or anomalies were observed.The customer complaint of blood within the catheter driveline was able to be confirmed by the photos.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of "blood in the driveline" was confirmed by visual inspection of the customer supplied photos.Blood was visible within the driveline of the iabc.However, full complaint verification testing could not be performed as no sample was returned for analysis.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 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 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: 23235088
• Report Number: 3010532612-2025-00985
• Device Sequence Number: 18618420
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: (01)00801902007247(11)250718(17)270630(10)18F25G0017(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 18F25G0017
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2025
• 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 Age: 61 YR
• Patient Sex: Female
• Patient Weight: 85 KG