MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "blood noted in iab gas line tubing for approximately 24 hours".Further information states "the blood has been reported to the md, but as of this time, they have not removed the iab".Additional information received states the iab was eventually removed.A second iab was placed in the same insertion site.No patient injury or consequence reported.Patient condition reported as "fine".

Event Description

It was reported that "blood noted in iab gas line tubing for approximately 24 hours".Further information states "the blood has been reported to the md, but as of this time, they have not removed the iab".Additional information received states the iab was eventually removed.A second iab was placed in the same insertion site.No patient injury or consequence reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.Returned for investigation was a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the supplied return kit and was in a sealed biohazard bag.Upon return, the short driveline tubing was noted cut.The cut section of the short driveline tubing, including the one-way valve, was not returned with the sample.The iabc bladder was noted withdrawn through the teflon sheath and the teflon sheath was noted on the iabc bladder membrane.The distal end of the teflon sheath was at approximately 6.6cm from the iabc distal tip.The sheath sidearm was noted cut and not returned.Buckling to the teflon sheath extrusion was noted at approximately 14.1cm to 14.9cm from the distal end of the teflon sheath.The exposed section of the bladder was fully unwrapped.The iabc was noted kinked at approximately 6.5cm from the iabc distal tip.A dried yellow media was noted on the exterior surfaces of the returned sample.Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc helium pathway.The customer photo submitted was reviewed; it shows blood within the helium pathway of the iabc driveline tubing, which is consistent with the reported complaint.Since the iabc bladder was noted withdrawn through the teflon sheath and buckling to the sheath, an in-service has been requested to review the instructions for use (ifu) with the customer.The instructions for use (ifu) states: "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing , dissection or balloon damage." 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 not returned with the sample; therefore, it could not be tested.A lab inventory short driveline tubing and one-way valve were assembled to the returned iabc.The one-way valve was connected to the short driveline tubing and a vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was removed from the bladder and towards the bifurcate without difficult.Upon removal and visual inspection, damage was noted to the iabc central lumen and bladder.The iabc central lumen within the flex-tip assembly area was noted damaged; the entire flex-tip assembly was noted no longer attached and separated from the inner cannula (iabc central lumen) at approximately 6.5cm from the iabc distal tip.The iabc bladder was noted pierced by the damaged central lumen at approximately 8.7cm from the iabc distal tip.A bend to the central lumen was noted at approximately 5.9cm from the iabc distal tip.The iabc was leak tested and numerous leaks were detected from the bladder.The bladder leak site at 8.7cm from the iabc distal tip was previously noted, as the damaged central lumen remained pierced through the bladder at this location.A bladder leak site was located near the distal end of the bladder; this leak site was a puncture, consistent with contact from a sharp object, and was noted at approximately 2.3cm from the iabc distal tip.Additionally , three (3) bladder leak sites are consistent with contact from the damaged central lumen or a sharp object; these three leak sites were noted around the circumference of the bladder at approximately 12.2cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance and the guidewire could not advance at approximately 5.0cm from the iabc distal tip due to a blocked central lumen.Some blood was noted on the guidewire.The central lumen was likely blocked by dried blood.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 60.2cm from the iabc luer.The guidewire was able to advance through the central lumen with the use of forceps.The guidewire exited the central lumen the location of the inner cannula separation.Blood had exited the central lumen with the guidewire.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 of iab blood in helium pathway is confirmed.During the investigation of the returned device, blood was confirmed within the helium pathway.Upon return, there was a damaged central lumen , and the bladder was noted with multiple leak sites.Either damage can result in a helium pathway leak and cause blood to enter the helium pathway.Due to the combined damages, it could not be confidently determined which damage occurred first or what initially caused blood to enter the helium pathway.Unrelated to the reported complaint, the returned iabc bladder was found withdrawn through the teflon sheath and buckling was noted to the sheath extrusion.This indicates the user did not follow the instructions for use (ifu) and could result in damage to the device.As a result, an in-service has been requested to review the ifu with the customer.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 blood in the helium pathway.The root cause of how the blood entered the helium pathway is undetermined.No further action required at this time.This will be monitored for any developing trends.

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18672351
• MDR Text Key: 334980992
• Report Number: 3010532612-2024-00100
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F21M0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GETINGE PUMP.; GETINGE PUMP.
• Patient Sex: Female