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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during the insertion of the sheath tube into the body, a bend occurred and was unable to be inserted into the patient's body".Additional information states that the iab catheter was removed and replaced in a different insertion site.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "during the insertion of the sheath tube into the body, a bend occurred and was unable to be inserted into the patient's body".Additional information states that the iab catheter was removed and replaced in a different insertion site.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The lot number reported is 18f25a0026.Returned for investigation were two 8.0fr teflon sheath with dilator assembly and a pre-dilator from a semi-finished insertion kit for a 30cc ultraflex intra-aortic balloon catheter (iabc).The sample was returned in a cardboard box and was in a sealed ziploc bag.Upon return, each dilator was noted to be fully inserted within the corresponding teflon sheath.Each dilator was removed from its corresponding teflon sheath without any difficulty.The hub of each dilator and pre-dilator appeared typical.Upon further inspection, the tip of each dilator, includ-ing the pre-dilator, was found to be damaged/split; the appearance of each dilator tip, including the pre-dilator tip, showed an inconsistent diameter with damage to the material at the tip opening.Some dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the interior surfaces of the returned sample.No other damage or abnormalities were noted.The tips and hubs of both teflon sheaths appeared typical.Some dried blood was noted on the exterior surfaces of each sheath.No damage or abnormalities were noted.Each returned dilator, teflon sheath and pre-dilator was aspirated and flushed successfully.No abnormalities or debris were 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 a "bend occurred and was unable to be inserted into the patient's body" is confirmed.During the investi gation, each returned dilator including the pre-dilator was found to be damaged/split at the tip.The appearance of each dilator tip, including the pre-dilator tip, showed an inconsistent diameter with damage to the material at the tip opening.The cause of the damage is undetermined.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 dilator tip.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.

• 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: 23610116
• Report Number: 3010532612-2025-01143
• Device Sequence Number: 13212805
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250110(17)261231(10)18F25A0026(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): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F25A0026
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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