MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06850-U
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "catheter placed for ep procedure and when they tried to remove through the balloon noted to be "wrapped" up at the distal end which had not happened before.Upon questioning the balloon was attempted to be removed from through the sheath.No issues or alarms were reported during iabp use on the patient".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "catheter placed for ep procedure and when they tried to remove through the balloon noted to be "wrapped" up at the distal end which had not happened before.Upon questioning the balloon was attempted to be removed from through the sheath.No issues or alarms were reported during iabp use on the patient".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The serial number on the sample is (b)(6).The lot number on the returned sample is 18f24j0043.Returned for investigation was a 50cc 8fr 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 iab bladder membrane; blood was noted in the sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was fully un-wrapped.Bends to the central lumen were noted at approximately 23cm, 24cm, 42cm, 53cm and 60cm from the distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the bladder/helium pathway.According to the event details, the user attempt-ed to remove the balloon through the sheath, which indicates that they did not follow the instructions for-use (ifu).As a result, a clinical specialist reviewed the ifu with the customer to explain the proper removal technique.The customer photos were reviewed.The photos show the blood on the iabc bladder membrane.The bladder thickness was measured at six points with measurements ranging from 0.0061in-0.0071in 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.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were de-tected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guide-wire was back loaded through iabc distal tip.The guidewire met resistance and could not advance at approximately 22.3cm from the iabc distal tip, which is the location of the previously noted bend.Some blood and debris were noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 22cm from the iabc luer; which is the location of the previously noted bend.Some blood and debris were noted on the guidewire.A de-vice 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 "balloon was attempted to be removed from through the sheath" is con-firmed based on the event details and returned state of the device.According to the event details, the user attempted to withdraw the catheter balloon through the teflon sheath, which indicates that the user did not follow the instructions-for-use (ifu).As a result, a clinical specialist reviewed the ifu with the customer to explain the proper removal technique.Based on a review of the device history record (dhr), the product met specification upon release.The most probable root cause of the complaint is user related.No further action is required at this time.

• Brand Name: ARROW ULTRAFLEX IAB: 8FR 50CC
• 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: 23645648
• Report Number: 3010532612-2025-01184
• Device Sequence Number: 21359298
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)240920(17)260831(10)18F24J0043(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F24J0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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: Male