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	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "iab abrasion/rupture".Additional information states that " blood in gas line.Patient is very pump dependent.Iab removed and replaced, wire placed same asscess site.No issues with removal or reinsertion.Patient stable with no alarms or issues with new iab." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Upon return, the teflon sheath was noted connected to the hemostasis cuff; blood was noted in the sidearm.The short driveline tubing was not connected to the iab bifurcate.The supplied 30cc driveline tubing was noted connected to the returned short driveline tubing; dried blood was noted in the tubing.The one-way valve was tethered to the short driveline tubing.The bladder was fully un-wrapped.The iabc distal tip was in the bladder.The fos fiber was noted cut.A bend to the iabc central lumen was noted at approximately 70cm from the iabc luer.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The submitted photos were reviewed.The photos show blood in the helium pathway, which is consistent with the reported complaint.The bladder thickness was measured at six points with measurements ranging from 0.0057in-0.0062in and was within specification of process document.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.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 tested in accordance with testing methods from manufacturing procedure.Two leaks were immediately detected from the bladder membrane.Under microscopic inspection, a total of two (2) repeated leak sites consistent with contact from a sharp object were noted around the circumference of the bladder at approximately 74.7cm to 75.2cm and 74.6cm to 74.8cm from the iabc luer.No other leaks were detected.A lab inventory 0.025in guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 70.3cm from the iabc luer, which is the location of the previously noted bend.Some blood and debris were 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 that "iab abrasion / rupture" is confirmed.During the investigation, two (2) punctures consistent with contact from a sharp object were found on the iabc bladder and caused the reported complaint.No other leaks were detected during functional testing.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 leaks.The root cause of the complaint is undetermined; a potential root cause is customer handling.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "iab abrasion/rupture".Additional information states that " blood in gas line.Patient is very pump dependent.Iab removed and replaced, wire placed same asscess site.No issues with removal or reinsertion.Patient stable with no alarms or issues with new iab." 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20724809
• Report Number: 3010532612-2024-00976
• Device Sequence Number: 6489251
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: (01)00801902034724(11)231031(17)250930(10)18F23K0013(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/21/2024

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: 09/30/2025
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F23K0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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: 83 YR
• Patient Sex: Female