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 Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) other remarks: n/a, corrected data: n/a.
Event or Problem Description
It was reported that "after the catheter inserted into the patient, the central lumen damaged." as a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No delay to therapy.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the serial number on the returned sample is (b)(6).The lot number recorded on the complaint report matches the lot number on the returned original packaging box and for the returned sam-ple.Returned for investigation was a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number of the returned sample.The sample was returned in a cardboard box and was loosely packed within the original packaging tray/carton.Upon return, the peel away sheath was noted on the iabc outer lumen.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The wire-round was noted unraveled and the iabc central lumen was noted damaged, consistent with being bro-ken at approximately 5.2cm from the iabc distal tip.Dried blood was noted on the exterior sur-faces of the returned sample.Some dried blood was noted within the iabc bladder/helium path-way.No other visual damage or abnormalities were noted to the returned sample.The customer submitted photos were r eviewed.In the photos, the iabc central lumen was noted broken near the iabc distal tip, which is consistent with the reported event.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 accord-ing to quality system document.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in the bladder in-flation, which is consistent with the previously confirmed broken central lumen.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was im-mediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire exited the central lumen and entered the bladder at the previously noted central lumen break.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire exited the central lumen and entered the bladder at the previously noted central lumen break.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 for "central lumen damaged" is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc distal tip, which caused the reported complaint.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 broken central lumen.The root cause of the complaint is unde-termined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "after the catheter inserted into the patient, the central lumen damaged." as a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No delay to therapy.No patient harm or injury.The patient status 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: 24273098
• Report Number: 3010532612-2026-00093
• Device Sequence Number: 10723274
• Product Code: DSP
• UDI-Device Identifier: 10801902145625
• UDI-Public: (01)10801902145625(11)250422(17)270331(10)18F25D0075(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F25D0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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