MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S840C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported ", the catheter was inserted into the patient, when the nurse aspirate before flushing the catheter, continuous bubbles appeared in the liquid pipe.The ap sensor was removed to release the air and the pipe was reconnected.However, when the suction was performed again, there were still bubbles.The ap sensor and the extension tube were replaced, but the situation did not improve.After communicating with the engineer, it was suspected that the leakage at the y-shaped connection caused this situation.Change the new catheter".No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported ", the catheter was inserted into the patient, when the nurse aspirate before flushing the catheter, continuous bubbles appeared in the liquid pipe.The ap sensor was removed to release the air and the pipe was reconnected.However, when the suction was performed again, there were still bubbles.The ap sensor and the extension tube were replaced, but the situation did not improve.After communicating with the engineer, it was suspected that the leakage at the y-shaped connection caused this situation.Change the new catheter".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).The lot number for the returned sample is (b)(6).Additional information obtained from a teleflex representative indicates the returned sample is the correct iabc for this complaint.Returned for investigation was a 40cc 8.0fr rediguard intra-aortic balloon catheter (iabc) with the original packaging box that does not match the serial number of the returned sample.The sample was returned in a cardboard box and was in a yellow bio-hazard bag/original carton.Upon return, the iabc bladder was noted withdrawn through the super arrow-flex (saf) sheath and the sheath was noted on the iabc bladder membrane cover-ing the iabc distal tip.The one-way vale was connected and tethered to the short driveline tubing.The visible section of the bladder was fully unwrapped.Upon further investigation, a total of 4 (four) cracks were noted on the iabc bifurcate luer.The total length of the crack #1 noted on the bifurcate luer was 0.85cm.The total length of the crack #2 noted on the bifurcate luer was 0.7cm.The total length of the crack #3 noted on the bifurcate luer was 0.45cm.The total length of the crack #4 noted on the bifurcate luer was 0.55cm.Dried blood was noted on the exterior surfaces of the returned iabc.No blood was noted within the helium pathway.The customer submitted video was reviewed.In the video, bubbles were noted within the arterial pressure tubing.The iabc bladder was noted withdrawn through the super arrow-flex (saf) sheath, which indicates the iabc was not removed from the patient correctly per the instructions for use (ifu).As a result, an in-service has been re-quested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage.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 (b)(4).Despite the damaged central lumen, the iabc central lumen was injected with air while beneath water, and leak was immediately found at the luer end of the iabc bifurcate.The leak occurred through the previously noted cracks noted on the luer end of the bifurcate.The catheter was unable to be aspirated and flushed successfully due to the cracks on the iabc luer end.The one-way valve was connected to the short driveline tubing and a vacuum was pulled on the returned iabc.While maintaining the vacuum, the super arrow-flex (saf) sheath was unable to be moved towards the iabc bifurcate.Then the saf sheath was re-moved entirely from the iabc bladder with some force.Upon removal of the sheath, the iabc blad-der appeared typical with no visual damage or abnormalities noted.The iabc was leak tested in ac-cordance with testing methods from manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.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.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 the "leakage at the y-shaped connection" is confirmed.During functional testing, a total of 4 cracks were found at the injection site of the iabc bifurcate for the central lu-men, which caused the reported complaint.The cracked bifurcate luer could allow a leak to occur at the injection site of the central lumen.Unrelated to the reported complaint, the returned iabc bladder was found withdrawn through the super arrow-flex (saf) sheath.This indicates the user did not follow the instructions for use (ifu) and could result in damage to the device.As a result, an in-service has been requested to review the ifu with the customer.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 cracks on the bifurcate luer.The probable root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.

• Brand Name: ARROW REDIGUARD IAB: 8FR 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: 22955324
• Report Number: 3010532612-2025-00821
• Device Sequence Number: 9591128
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: (01)00801902002679(11)240712(17)260630(10)18F24G0030(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981660
• 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): 08/06/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F24G0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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