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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during the process of implanting the catheter into the patient, the front end of the balloon was bent and could not be implanted inside the patient's body.After removal, it was found that the front end of the balloon was bent".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".
Event or Problem Description
It was reported "during the process of implanting the catheter into the patient, the front end of the balloon was bent and could not be implanted inside the patient's body.After removal, it was found that the front end of the balloon was bent".Additional information states that the iab catheter was removed and repalced.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 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging box.The sample was returned in a cardboard box and was in a ziploc bag.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.A bend to the central lumen was noted at approximately 5cm and 36cm from the distal tip.No 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 bladder thickness was measured at six points with measurements rang-ing from 0.0051in-0.0060in 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.A leak was immediately detected from the iabc b ladder membrane at approximately 26.6cm from the distal tip.The leak site was consistent with contact from a sharp object; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.Resistance was noted at approximately 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 "front end of the balloon was bent" is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted bent and resistance was noted upon passing the guidewire through the iabc central lumen.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 bent central lumen.The root cause of the bent central lumen is undetermined.No further action is required at this time.The reported complaint will be mon-itored for any developing trends.

• 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: 23633488
• Report Number: 3010532612-2025-01168
• Device Sequence Number: 10477306
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: (01)00801902026804(11)250331(17)270228(10)18F25C0135(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): 10/29/2025

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-06840-U
• Device Lot Number: 18F25C0135
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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