MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05830-LWS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported " the catheter did not zero before insertion, which is not always unusual.We swapped the consoles which didn't make any difference to being able to use it.After insertion into the patient and activating the pump the balloon catheter registered an error helium leak on the console.It was removed immediately and another catheter was opened".Additional information states that the second catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported " the catheter did not zero before insertion, which is not always unusual.We swapped the consoles which didn't make any difference to being able to use it.After insertion into the patient and activating the pump the balloon catheter registered an error helium leak on the console.It was removed immediately and another catheter was opened".Additional information states that the second catheter was inserted into the same insertion site.No patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The serial number on the returned sample is mm30102.Returned for investigation was a 30cc 8.0fr fos 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 shipping pouch and was loosely packed within the original packaging carton.Upon return, the teflon sheath was noted on the returned iabc.The one-way valve was tethered to the short driveline tubing.The iabc bladder was fully unwrapped.A kink to the iabc central lumen was noted at approximately 31.4cm from the iabc distal tip.Spots of dried blood were noted on the exterior surfaces of the returned iabc.No blood was noted within the helium pathway.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.The cal key was examined, and no damage was noted.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 and then 30 seconds five separate times according to quality system document.The cal key and fos were connected to the iabp.The cal key was recognized.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The fiber was found broken approximately 22.7cm from the iabc distal tip.The full length of the fiber was confirmed present with no other notable breaks.The iabc 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.An external leak was immediately detected from the bifurcate around the fos adhesive.Upon microscopic inspection, an external leak occurred from the fos adhesive bond at the bifurcate.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire could not advance at approximately 31.5cm from the iabc distal tip, which is the location of the previously noted kink.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 45.6cm from the iabc luer, which is the location of the previously noted kink.No blood or debris was noted.A device history record (dhr) review was c onducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint for iab "balloon catheter registered an error helium leak" is confirmed.During the investigation, an external helium leak was confirmed from the iabc bifurcate fos adhesive.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 leak at the bifurcate fos adhesive.The probable root cause of the bifurcate fos adhesive leak is manufacturing related.A non-conformance has been initiated to further investigate the issue related to the leak from bifurcate fos adhesive.

• Brand Name: ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 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: 21020317
• Report Number: 3010532612-2024-01133
• Device Sequence Number: 18430857
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)231228(17)251130(10)18F23M0056(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021462
• 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): 12/02/2024

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: 11/30/2025
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F23M0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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