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	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "user was initiating the iab therapy for a patient following instruction of use, user had combine the dilator with sheath and locked, then user removed the dilator from sheath but found that the luer lock had dislodged from the dilator and it still lock with the sheath.User remove the entire items, and used another arrow 30cc iab to complete the procedure without any problem".No patient injury or consequence reported.The patient's current condition is reported as "fine".At the time of this report, the customer hasnt responded to our requests for additional information.
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 re-turned in a cardboard box and was in a clear plastic bag.Returned with the sample was 8fr dilator from the supplied semi-finished insertion kit.Upon return, the locknut adapter (part of the dilator, which locks the dilator to the sheath) was found to be separated and no longer attached to the re-turned 8fr dilator hub.The locknut adapter in question and sheath were not returned with the sample.No other damage or abnormalities were noted to the returned dilator.The tip and hub of the re-turned dilator appeared typical.No blood was noted on the interior or the exterior surfaces of the returned dilator.The one-way valve was noted connected and tethered to the short driveline tubing.The bladder was fully unwrapped.No blood was noted on the interior or the exterior surfaces of the returned iab catheter.No visual damage or abnormalities were noted to the returned iab catheter.The customer submitted photos were reviewed.In the photo the locknut adapter was noted separat-ed and no longer attached to the 8fr dilator hub, which is consistent with the reported event.In the photo , the user showed the comparison of the good dilator, where the locknut adapter is attached to the dilator hub vs the dilator in question with the locknut adapter separated and no longer attached to the dilator hub.The returned dilator was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.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 abnormal-ities or debris were noted.The iabc was leak tested in accordance with testing methods from manu-facturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in g uidewire was back loaded through the iabc distal tip.No resistance was noted; 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 "luer lock had dislodged from the dilator" is confirmed.During the investigation, the locknut adapter was found to be separated and no longer attached to the returned dilator hub.It could not be confidently determined what led to the separation of the locknut adapter from the dilator hub.The locknut adapter in question and sheath were not returned with the sample.The returned iab catheter passed functional testing.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 locknut adapter separation.The root cause of the com-plaint is undetermined.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "user was initiating the iab therapy for a patient following instruction of use, user had combine the dilator with sheath and locked, then user removed the dilator from sheath but found that the luer lock had dislodged from the dilator and it still lock with the sheath.User remove the entire items, and used another arrow 30cc iab to complete the procedure without any problem".No patient injury or consequence reported.The patient's current condition is reported as "fine".At the time of this report, the customer hasn;t responded to our requests for additional informaiton.

• 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: 22964334
• Report Number: 3010532612-2025-00835
• Device Sequence Number: 9113833
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250204(17)270131(10)18F25A0092(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 18F25A0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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