MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05830-LWS-SC
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "concern for clots after not moving for 30min.[nurse] called to troubleshoot alarms on getinge iabp.They had exchanged the console prior to call and getinge recommended calling teleflex d/t thinking alarms were iab related.On the alternate getinge console, alarms persisted.Patient still and flat.No blood in the driveline and connections tight.Alarms issued within 5s of attempts to restart the console.[nurse] to report that had not been able to get the getinge pump started and the md opted to discontinue the iab due to the risk of clot formation on the membrane.Patient remained stable and no issues reported with removal." no patient injury or consequence reported.The patient status is reported as "fine.".
Additional Manufacturer Narrative
Qn#(b)(4).The product was not returned for investigation.The picture provided was reviewed and shows the insertion site of the iabc.The peel away sheath and teflon sheath were both noted on the catheter.Based on the reported details, the customer was told that this was not prepped correctly and was instructed on proper insertion technique.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 "gas loss alarms" 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 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.
Event or Problem Description
It was reported that "concern for clots after not moving for 30min.[nurse] called to troubleshoot alarms on getinge iabp.They had exchanged the console prior to call and getinge recommended calling teleflex d/t thinking alarms were iab related.On the alternate getinge console, alarms persisted.Patient still and flat.No blood in the driveline and connections tight.Alarms issued within 5s of attempts to restart the console.[nurse] to report that had not been able to get the getinge pump started and the md opted to discontinue the iab due to the risk of clot formation on the membrane.Patient remained stable and no issues reported with removal." no patient injury or consequence reported.The patient status is reported as "fine.".

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC
• 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: 22462144
• Report Number: 3010532612-2025-00611
• Device Sequence Number: 20990898
• Product Code: DSP
• UDI-Device Identifier: 10801902218909
• UDI-Public: (01)10801902218909(11)241107(17)261031(10)18F24L0026(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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 Catalogue Number: IAB-05830-LWS-SC
• Device Lot Number: 18F24L0026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown