MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06840-U
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported ", the iabp alarmed, and the balloon waveform indicated catheter kinking.Examination revealed that the hemostasis cuff had detached from the hemostasis sheath introducer.The exposed shaft was contaminated and could not be reinserted into the patient.The catheter was replaced with a new set, and assistance for the patient was continued".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported ", the iabp alarmed, and the balloon waveform indicated catheter kinking.Examination revealed that the hemostasis cuff had detached from the hemostasis sheath introducer.The exposed shaft was contaminated and could not be reinserted into the patient.The catheter was replaced with a new set, and assistance for the patient was continued".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Upon further review, it was determined that this complaint was created in error, thus, the initial mdr submitted on 24 march 2026 should be retracted.

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 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: 24681258
• Report Number: 3010532612-2026-00250
• Device Sequence Number: 15895417
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)250418(17)270331(10)18F25D0044(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F25D0044
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown