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	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "balloon rupture".Additional information stated that the catheter was removed and not replaced.The customer reported no harm to the patient.No other details from the customer have been provided.
Event or Problem Description
It was reported "balloon rupture".Additional information stated that the catheter was removed and not replaced.The customer reported no harm to the patient.No other details from the customer have been provided.
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).No lot number was reported.Returned for investigation a 50cc 8.0fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Returned with the sample was the supplied 50cc driveline; liquid blood was noted in the tubing.Upon return, the teflon sheath was noted connected to the hemostasis cuff; the sheath was noted buckled.A red cap was noted on the iabc luer.The iabc bladder was fully unwrapped.Bends to the iabc central lumen were noted at approximately 1.7cm, 5.2cm and 43cm from the iabc distal tip.Damage was noted to the outer lumen consistent with being pinched or crushed at approximately 33.1cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0062in-0.0079in and was within specification of process document.An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to a blocked central lumen.Immediate push back on the syringe plunger was experienced.The blockage was most likely dried blood.The iabc was leak in accordance with testing methods from manufacturing procedure.A leak was immediate-ly detected from the bladder membrane.Under microscopic inspection, abrasions were observed from approximately 22cm to 24.5cm from the iabc distal tip.A full thickness abrasion to the bladder was confirmed at approximately 23.5cm from the iabc distal tip and the appearance was consistent with repeated contact with calcified plaque on the aortic wall.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 1.7cm and 5cm from the iabc distal tip.The guidewire met resistance and could not advance at approximately 44cm from the iabc distal tip, which is the location of the previously noted bend.Some blood and debris were noted.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 38cm from the iabc luer, which is the location of the previously noted bend.Some blood and debris were noted.A device his-tory 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 "balloon rupture" is confirmed.The intra-aortic balloon catheter (iabc) bladder had a full thickness abrasion, which caused the blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.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 bladder leak.The root cause of the bladder leak is related to patient condition.No further action required at this time.The complaint will be monitored for any developing trends.

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21026432
• Report Number: 3010532612-2024-01122
• Device Sequence Number: 21088218
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192(11)231205(17)251130(10)18F23L0058(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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-06850-U
• Device Lot Number: 18F23L0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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