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	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned for investigation was a 30cc 8fr fiberoptix ultra intra-aortic balloon catheter (iabc).Upon return, the teflon sheath was noted on the iabc bladder; dried blood was noted was noted in the sidearm.The visible portion of the bladder was fully unwrapped.The one-way valve was tethered to the short driveline tubing.The supplied 60cc syringe was noted connected to the one-way valve.Bends to the iabc central lumen were noted at approximately 5cm and 59.5cm from the iabc distal tip.A kink to the iabc outer lumen was noted at approximately 59.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The fos cable was visually inspected; no damage or abnormalities were noted.No visual fos fiber breaks were noted.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 bladder thickness was measured at six points with measurements ranging from 0.0055in-0.0064in.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.The cal key and fos were connected to the iabp without difficulty.The pump displayed "fos sensor connected, connect cal key to zero" and displayed fos status "ck" (cal key), indicating that the cal key was not recognized by the iabp.The cal key was removed and rotated 180 degrees and then reinserted with the same result.The fos cal key was visually inspected again, and no damage was noted.The fos could not be autozeroed by the pump due to the unrecognized cal key.Upon further inspection , the fos fiber was found fully intact.The iabc central lumen was aspirated and flushed using a 60cc lab inventory syringe.No abnormalities or debris were noted.The one-way valve was connected to the short driveline tubing and a negative vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was moved towards the iabc bifurcate with little force.The iabc was leak tested.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 and the appearance of the adhesive is consistent with showing a void.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through iabc distal tip.Resistance was noted at approximately 5cm from the iabc distal tip, which is the location of the previously noted bend.The guidewire met resistance and could not advance at approximately 60cm 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 approximately 17.5cm from the iabc luer, which is the location of the previously noted bend.No blood or debris was noted.The reported complaint for "frequent possible helium loss alarms" is confirmed.During the investigation, an external 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 root cause of the leak at the.Bifurcate fos adhesive is manufacturing related.A non-conformance has been initiated to further investigate the issue.
Event or Problem Description
It was reported "frequent possible helium loss alarms when starting therapy after insertion in the cath lab".To continue therapy, another iab catheter was inserted of a different brand and worked fine.No patient injury or consequence reported.The patient's current condition is reported as "fine".

• 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 20148647
• Report Number: 3010532612-2024-00723
• Device Sequence Number: 4237249
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)240319(17)260228(10)18F24C0101(21)
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 08/06/2024

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: 02/28/2026
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F24C0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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: Female