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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "after the catheter inserted, the blood was found in helium pathway and remove difficulty".Additional information states that the iab catheter was removed and replaced.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 7.5fr ultraflex intraaortic 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 teflon sheath was noted on the iabc.The one-way valve was noted connected and tethered to the short driveline tubing.The iabc outer lumen was noted damaged consistent with being stretched.The damage to the outer lu-men most likely occurred during device removal due to the difficulty encountered.A significant amount of dried blood was noted within the helium pathway, which likely contributed to the removal difficulty.The iabc bladder was fully unwrapped; the bladder was also noted bunched up due to the stretched outer lumen.Dried blood was noted on the exterior surfaces of the returned sample.The bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0064in and was within specification of process document.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.The one-way valve was properly cleaned and tested again; the one-way valve 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.Blood exited.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the bladder membrane.Under microscopic inspection, a cut consistent with contact from a sharp object was noted on the iabc bladder at approximately 22.6cm to 23cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.Blood was noted on the guidewire upon removal.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 for "blood was found in helium pathway and remove difficulty" is confirmed.During the investigation, a puncture consistent with contact from a sharp object was found on the iabc bladder, which allowed blood to enter the helium pathway.In addition, a significant amount of dried blood within the helium pathway can cause the removal difficulty.Based on a review of the de-vice history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the bladder leak.The probable root cause is customer handling related.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "after the catheter inserted, the blood was found in helium pathway and remove diffiuclty".Additional information states that the iab catheter was removed and replaced.The patient's current condition is reported as "fine".

• 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: 23532397
• Report Number: 3010532612-2025-01096
• Device Sequence Number: 13028040
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: (01)00801902003751(11)250331(17)270331(10)18F25C0132(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): 10/15/2025

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: 18F25C0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown