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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "after the catheter inserted, the balloon can not inflate completely, change the new catheter".Additional information states that the iab catheter was removed and replaced.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number for the returned sample.The sample was returned in a cardboard box and was loosely packed.Returned with the sample was a 30cc inflation driveline tubing.Upon return, the teflon sheath was noted on the iabc; the sheath was noted buckled.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Bends to the central lu-men were noted at approximately at approximately 34cm, 39.5cm, 48.5cm, 52cm, 61cm, 65cm, and 75cm from the luer.The central lumen was noted broken at approximately 1.4cm from the iab distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway; the catheter was likely cleaned prior to return.The teflon sheath was noted buckled, which indicates the iabc was not removed correctly per the instructions for use (ifu).The instructions for use (ifu) states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage.The bladder thickness was measured at six points with measurements ranging from 0.0 058in-0.0064in and was within specification of process document.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 aspi-rate and flush the iabc c entral lumen using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked/ clotted central lumen.Upon aspiration, water was unable to be pulled into the syringe.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.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 confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and luer end blocked off; a leak was immediately detected from the bladder membrane.Under microscopic inspection, a leak site consistent with contact from a sharp object was noted on the bladder at approximately 17.7cm from the iabc distal tip.No other leaks were detected.It could not be confidently determined which damage occurred first.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire exited the central lumen and entered the bladder at the location of the broken central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 39.5cm from the luer; which is the location of the previously noted bend.No blood or debris 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 "the balloon cannot inflate completely" is confirmed.Upon return, various damages were noted to the iab catheter.The central lumen was noted damaged and a leak site, consistent from contact with a sharp object, was noted on the bladder membrane.Due to the returned state of the device, it could not be confidently determined what initially caused the 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 iab catheter.The root cause of the complaint is undetermined.This will be monitored for any developing trends.
Event or Problem Description
It was reported "after the catheter inserted, the balloon can not inflate completely, change the new catheter".Additional information states that the iab catheter was removed and replaced.No patient injury or cosnequence reported.The patient's current condition is reported as "fine".

• 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: 24767783
• Report Number: 3010532612-2026-00287
• Device Sequence Number: 18716795
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)241210(17)261130(10)18F24M0028(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): 03/06/2026

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: 18F24M0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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
• Patient Sex: Unknown