MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06850-U
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot number recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 50cc 8fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging label that matches the serial number on the returned sample.Returned with the sample was 8.5fr sheath & dilator assembly; the teflon sheath extrusion was noted damaged/buckled.Upon return, the teflon sheath was noted on the returned sample; liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.The iabc central lumen was noted broken at two different locations, within the flex-tip assembly area at approximately 5.8cm and 6.4cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Some dried blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0072in-0.0076in and was within specification.The one-way valve was tested and passed.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation.The results are consistent with the previously noted broken central lumen.A leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed broken central lumen.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; 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 5.9cm from the iabc distal tip, which is the location of the previously noted damaged/broken central lumen.Some blood noted on the guidewire upon removal.The guidewire was front loaded through the iabc luer.The guidewire exited the central lumen and entered the bladder at the location of the broken central lumen.Some blood noted on the guidewire upon removal.The reported complaint for iab "didn't unfurled" is confirmed.During the investigation, the intra-aortic balloon catheter (iabc) central lumen was noted broken in the flex-tip assembly area near the iabc distal tip.The damaged central lumen can result in blood entering the helium pathway and an inability of the bladder to fully inflate.The iabc bladder was fully intact with no damage noted.The probable root cause of the complaint is undetermined.
Event or Problem Description
It was reported "sheath folded in on itself.Iab didnt unfurl".Additional information states that to continue therapy, another iab catheter was inserted.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".

• Brand Name: ARROW ULTRAFLEX IAB: 8FR 50CC
• 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: 20557945
• Report Number: 3010532612-2024-00911
• Device Sequence Number: 3250488
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)230921(17)250831(10)18F23J0043(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 10/01/2024

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: 08/31/2025
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23J0043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2023
• 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 Sex: Unknown