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	Insufficient Information (4580)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "balloon ruptured when user observer had blood in the helium tubing".Additional information states that the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed ziploc bag.Upon return, the teflon sheath was noted on the iabc outer lumen.The one-way valve was noted tethered to the short driveline tubing.The iabc bladder was fully unwrapped.The iabc central lumen was noted bent at approximately 34.4cm, 53.5cm and 73cm from the iabc distal tip.The iabc central lumen was noted potentially broken at approximately 59.2cm from the iabc distal tip.No blood was noted on the exterior surfaces of the returned sample.Clear fluid was also noted within the helium pathway.The sample was most likely cleaned prior to its return.The customer submitted photos and videos were reviewed.The photos show the portion of the iab catheter.In the video, the user was injecting air using the syringe int o the iabc central lumen and liquid blood was noted coming out from the short driveline tubing, which indicates a crossover leak between the iabc central lumen and helium pathway.Blood was also noted within the iabc bladder.The video shows clear fluid was noted coming out from the distal end of the teflon sheath.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.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation and air leak through the iabc short driveline tubing indicating crossover leak between the iabc central lumen and helium pathway.The results are consistent with the previously noted damaged/broken central lumen at approximately 59.2cm from the iabc distal tip.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously noted damaged/broken central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 34.5cm and 53.5cm from the iabc distal tip, which are the locations of the previously noted bends.Then the guidewire could not advance at approximately 59.2cm from the iabc distal tip, which is the loca-tion of the previously noted damaged/broken central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 9.2cm from the iabc luer, which is the location of the previously noted bend.Then the guidewire could not advance at approximately 23.2cm from the iabc luer, which is the location of the previously noted damaged/broken central lumen.No blood or debris was noted.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 the helium tubing" is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken, 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 broken central lumen.The root cause of the broken central lumen is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported "balloon ruptured when user observer had blood in the helium tubing".Additional information states that the iab catheter was removed and not replaced.No patient injury or consequence reported.The patient's current condition is reported as "stable".

• 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: 24518624
• Report Number: 3010532612-2026-00189
• Device Sequence Number: 8515126
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)250805(17)270731(10)18F25G0167(21)
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 02/05/2026

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: 18F25G0167
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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