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

Catalog Number	IAB-05830-LWS
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "receiving a possible helium loss 3 alarm.Balloon does not appear to be fully unwrapped".A second catheter was inserted in the same insertion site.No patient injury or consequence.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 8.0fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed bio-hazard bag.Upon return, the supplied teflon sheath was noted on the returned sample; fluid/liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.Two bends to the iabc central lumen were noted at ap-proximately 23.3cm and 46cm from the iabc distal tip.Dried blood was noted on exterior surfaces of the returned sample.No obvious blood was noted within the iabc helium pathway.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clam-shell 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, and no abnormalities were noted.The customer video was reviewed.The video shows the fluoroscopic view of the patient/ iab catheter and the iabc bladder appeared not fully inflating in the video, 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 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 fos was connected and the iabp zeroed the iabc.The pump status dis-played "ok" indicating the fiber is fully intact.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.An external leak was immediately noted and located around the bifurcate bushing.Upon microscopic inspection, an external leak occurred at the proximal end of the bushing and the appearance is consistent with showing a void.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 23.2cm from the iabc distal tip, which is the location of the previously noted bend.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 for "possible helium loss 3 alarm and balloon does not appear to be fully unwrapped" is confirmed.An external leak is confirmed from the iabc bifurcate bushing.An external leak could result in an inability of the iabc to fully inflate and can cause the helium loss alarm.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 bushing.The root cause of the leak at the bifurcate bushing is manufacturing related.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported "receiving a possible helium loss 3 alarm.Balloon does not appear to be fully unwrapped".A second catheter was inserted in the same insertion site.No patient injury or consequence.The patient's current condition is reported as "fine.".

• Brand Name: ARROW FIBEROPTIX ULLTRA 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: 19744005
• Report Number: 3010532612-2024-00551
• Device Sequence Number: 7674043
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)231108(17)251031(10)18F23L0019(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 10/31/2025
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F23L0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Female