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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the catheter into the patient successfully.After 2 hours the blood was found in helium pathway and the doctor removed the catheter".Additional information states that the iab catheter was removed and not replaced.No patient injury or cosnequence 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).The lot number for the returned sample is 18f25a0027.Additional information obtained from a teleflex representative indicates the re-turned sample is the correct iabc for this complaint.Returned for investigation was a 30cc 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 teflon sheath was noted on iabc.The one-way valve was tethered to the short driveline tubing.The bladder was fully un-wrapped.The central lumen was noted bent at approximately 68cm from the distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Some blood was noted within the helium pathway.The customer submitted photo was reviewed.The photo shows blood in the inflation driveline tubing.The bladder thickness was measured at six points with measurements ranging from 0.0052in-0.0057in 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 im-mediately detected from the iabc bladder membrane at approximately 10cm 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.The guidewire met re-sistance and could not advance at approximately 67.8cm from the iabc distal tip, which is the location of the previously noted bend.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approxi-mately 9.2cm from the iabc luer; which is the location of the previously noted bend.No blood or debris was noted on the guidewire.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" is confirmed.During the investi-gation, a puncture consistent with contact from a sharp object was found on the iabc bladder and this caused the reported complaint.No other leaks were detected during functional testing.Based on a review of the device history record (dhr), the product met specification upon re-lease; 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 is required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "the catheter into the patient successfully.After 2 hours the blood was found in helium pathway and the doctor removed the catheter".Additional information states that the iab catheter was removed and not replaced.No patient injury or cosnequence reported.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: 23989382
• Report Number: 3010532612-2026-00023
• Device Sequence Number: 13317661
• Product Code: DSP
• UDI-Device Identifier: 10801902145625
• UDI-Public: (01)10801902145625(11)250113(17)261231(10)18F25A0027(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

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: 18F25A0027
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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