MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06830-U
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
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".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 "after the catheter inserted, the balloon can not inflate completely.Change the new catheter".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 returned sample is (b)(6).Returned for investigation was a 30cc 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 one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc central lumen was noted bent at approximately 35.3cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.No other visual damage or abnormalities were noted to the returned sample.The customer submitted photo was reviewed.In the photo, the iab catheter in question was loosely packed within the original packaging tray.In addition, the original packaging tray was noted with damage to the "arrow" packaging sticker during the review of the photo.The arrow sticker was noted cut/ripped.This packaging sticker is not to be removed.This condition indicates a potential that the catheter was not prepped per the instructions for use (ifu).As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states:"1.Connect one-way valve to male luer on short driveline tubing attached to iab.Insert supplied syringe into one-way valve.Slowly aspirate a full syringe of air.Precaution: the one-way valve will maintain vacuum on the balloon and must remain in place until is fully inserted.Remove syringe.2.Remove catheter from tray, keeping it in line with balloon membrane.3.Grasp catheter close to tray and pull it straight out of the holding sleeve.Note: keep catheter level with tray.Do not lift or bend during removal.The bladder thickness was measured at six points with measurements ranging from 0.0062in-0.0068in 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 iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was connected to an iabp w ith a lab inventory 30cc inflation driveline tubing.The iabc was inserted into the "t" tube and 75mmhg backpressure was applied.The iabc was pumped for a minimum of 15 minutes.There were no alarms triggered.The bladder inflated and deflated completely with each beat.The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 35.5cm from the iabc distal tip, which is the location of the previously noted bend.The guidewire was able to advance through the 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 that the "balloon cannot inflate completely" is not confirmed.The returned iabc bladder was fully intact with no abnormalities noted.During the investigation, the iabc fully inflated, and no leaks/alarms were noted.The returned device passed visual and functional test specifications.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Unrelated to the reported complaint, the original packaging tray was noted with damage to the "arrow" packaging sticker in the customer provided photo with the complaint report.This indicates the user did not follow the instructions for use (ifu) and could result in damage to the device.As a result, an in-service for the customer is requested to reiterate the appropriate method for iab prep/removal from its packaging.

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 30CC
• 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: 23154304
• Report Number: 3010532612-2025-00955
• Device Sequence Number: 12050496
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250121(17)261231(10)18F25A0030(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): 09/02/2025

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 Catalogue Number: IAB-06830-U
• Device Lot Number: 18F25A0030
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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