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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the catheter was inserted into the patient.The iabc balloon ruptured and blood in helium pathway.A new balloon was replaced and is now functioning normally".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "the catheter was inserted into the patient.The iabc balloon ruptured and blood in helium pathway.A new balloon was replaced and is now functioning normally".No patient injury or cosnequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).The lot number for the returned sample is 18f24m0136.Additional information obtained from a teleflex representative indicates the re-turned sample is the correct iabc for this complaint.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was in a bio-hazard bag.Upon return, the teflon sheath was noted on the returned iabc; the sheath extrusion was noted buckled and a portion was cut.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The bends to the central lumen were noted at approximately 28cm and 36cm.The outer lumen was noted damaged, consistent with being buckled at approximately 26.5cm to 28.5cm from the dis-tal tip.Dried blood was noted on the exterior surfaces of the returned sample.Some blood was noted within the bladder/helium pathway.The one-way valve was tested and passed.A vacuum was pulled on the one- way valve, and it held for at least 1 minute according to quality system document.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No blood or debris was noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.Multiple leaks were immediately detected from the iabc outer lumen at the locations of the previously noted damaged outer lumen.It could not be confidently determined how the damage occurred to the iab outer lumen.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.The guidewire met resistance and could not advance at approximately 60cm from the iabc distal tip.Some blood and debris was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 24cm from the iabc luer.Some blood and de-bris was noted on the guidewire.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 for "blood in helium pathway" is confirmed.During the investigation, the outer lumen was noted damaged, and leaks were noted resulting from the damaged outer lumen which caused the reported complaint.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 damaged outer lumen.The root cause of the outer lumen leaks is undetermined; a potential root cause is customer handling.No further action is required at this time.This will be monitored for any developing trends.

• 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: 24558396
• Report Number: 3010532612-2026-00206
• Device Sequence Number: 21192254
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)250102(17)261231(10)18F24M0136(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): 02/11/2026

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: 18F24M0136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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