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

Catalog Number IAB-06850-U

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that 15 minutes after the 50cc iab was inserted, the pump began to have persistent high pressure alarms.The balloon volume was decreased to 36cc, but the alarms continued.No blood was observed in the helium tubing at this time.30 minutes later, the doctor chose to remove the iab and insert a 2nd iab in the same insertion site.It was noted the original iab "appeared to have quite a lot of blood in it".The user denied that there had been any other alarms other than high pressure, nor that there was ever any blood seen in the tubing.The new 40cc iab is working "fine".No patient harm or injury.The patient status is reported as "critical.".

Event Description

It was reported that 15 minutes after the 50cc iab was inserted, the pump began to have persistent high pressure alarms.The balloon volume was decreased to 36cc, but the alarms continued.No blood was observed in the helium tubing at this time.30 minutes later, the doctor chose to remove the iab and insert a 2nd iab in the same insertion site.It was noted the original iab "appeared to have quite a lot of blood in it".The user denied that there had been any other alarms other than high pressure, nor that there was ever any blood seen in the tubing.The new 40cc iab is working "fine".No patient harm or injury.The patient status is reported as "critical".

Manufacturer Narrative

(b)(4).The reported complaint for iab blood in helium pathway was confirmed upon the investigation of the returned sample.The customer returned a 50cc 8.0fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging for investigation.Upon return, the distal end of the teflon sheath was noted at approximately 31cm from the iabc distal tip; liquid blood was noted within the sheath sidearm (inp-4, inp-9).The one-way valve was tethered to the short driveline tubing (inp-5).The supplied 50cc inflation driveline tubing was connected to the iabc short driveline tubing (inp-4, inp-5).The distal and proximal portion of the iabc bladder was noted wrapped (or considered twisted) (inp-6, inp-7, inp-8).The iabc central lumen was noted damaged within the flex-tip assembly area at approximately 5.2cm from the iabc distal tip (inp-7).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0068in-0.0077in and was within specification of process document.The one-way valve was tested and failed.A vacuum was pulled on the one-way valve, and it immediately lost pressure.This was repeated five separate times according to quality system document q-96 with similar results.Dried blood was noted within the one-way valve upon cleaning.The one-way valve was properly cleaned and tested again; the one-way valve 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 in accordance with quality system document.The catheter's central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.During the leak test, the bladder did not fully inflate.The middle portion of the bladder had inflated bu t the proximal and distal portion of the bladder would not fully unwrap and was consistent with being twisted (anp-1, anp-2, anp-3).No leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance and could not advance at approximately 5.1cm from the iabc distal tip, which is the location of the damaged central lumen (inp-7, anp-4, anp-5).No blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 76.9cm from the iabc luer, which is the location of the damaged central lumen (inp-7, anp-4, anp-5).No blood was noted on the guidewire.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 damaged central lumen.The root cause of the complaint was undetermined.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ULTRAFLEX IAB: 8FR 50CC
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18088408
• MDR Text Key: 328767681
• Report Number: 3010532612-2023-00620
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: 10801902144192
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23C0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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
• Patient Sex: Female