MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05840-LWS

Device Problem Material Twisted/Bent (2981)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

Reported as "suspected internal permanent kink".The report states that after insertion of the iab, pumping was started but the iabp immediately alarmed for "possible helium loss 3 alarm".The bpw appeared with severely widened inflation and deflation artifact.The balloon volume was decreased first to 35cc and then to 30cc.This did not resolve the issue and as a result, the iab was removed and a 2nd iab was inserted at the same insertion site with minimal interruption in therapy.The patient is being well supported by the pump.No patient harm or injury.The patient status is reported as "fine".

Event Description

Reported as "suspected internal permanent kink".The report states that after insertion of the iab, pumping was started but the iabp immediately alarmed for "possible helium loss 3 alarm".The bpw appeared with severely widened inflation and deflation artifact.The balloon volume was decreased first to 35cc and then to 30cc.This did not resolve the issue and as a result, the iab was removed and a 2nd iab was inserted at the same insertion site with minimal interruption in therapy.The patient is being well supported by the pump.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The reported complaint of iab "suspected internal permanent kink" was not able to be confirmed as the product was not returned for investigation.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 root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.

Manufacturer Narrative

Qn#(b)(4).Returned for investigation was a 40cc 8.0fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging.The serial number (b)(6) recorded on the complaint report matches the serial number on the returned sample.Upon return, the iabc bladder was noted withdrawn through the teflon sheath and the sheath was noted on the iabc bladder membrane.The distal end of the teflon sheath was noted at approximately 0.5cm from the iabc distal tip; dried blood was noted within the sheath sidearm.Bucking was noted to the teflon sheath extrusion at approximately 13.2cm to 15.3cm from the distal end of the teflon sheath.The one-way valve was noted connected and tethered to the short driveline tubing.The visible portion of the iabc bladder was fully unwrapped.A kink to the iabc central lumen was noted at approximately 45.7cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No blood was noted within the helium pathway.The fos connector and cal key were examined.The fos gray connector was properly seated in the blue clamshell housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.Since the iabc bladder was noted withdrawn through the teflon sheath and buckling was noted to the sheath extrusion, which indicates the iabc was not removed from the patient correctly per the instructions for use (ifu).As a result, 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 one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at lea st 1 minute and then 30 seconds five separate times.The cal key and fos were connected to the iabp.The cal key was recognized.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber.The fiber was found broken approx imately 27.9cm from the iabc distal tip.No other fiber breaks were noted.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.During the flush, the visible portion of the bladder had slightly inflated, which indicates a crossover leak between the iabc central lumen and the helium pathway.No blood or debris were noted.The one-way valve was connected to the short driveline tubing and vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was moved from the bladder and towards the bifurcate with some force required.Upon removal of the teflon sheath, the iabc bladder appeared typical; no visual damage or abnormalities were noted.The iabc was leak tested and a leak was immediately detected from the iabc distal tip and iabc luer end.Upon further inspection, the iabc central lumen within the flex-tip assembly area was noted damaged; the wire round/polyimide (part of the flex tip assembly) was noted partially broken at approximately 5.9cm from the iabc distal tip.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.No blood was noted within the iabc helium pathway upon receipt of the sample, which indicates that the central lumen break at this location likely occurred as a result of the bladder withdrawal through the teflon sheath.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 6cm from the iabc distal tip, which is the location of the previously noted damaged central lumen within flex-tip assembly area.The guidewire could not advance at approximately 45.7cm from the iabc distal tip, which is the location of the previously noted kink.No blood or debris was noted.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 37.2cm from the iabc luer, which is the location of the previously noted kink.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all man ufacturing specifications prior to release.The reported compliant that "suspected internal permanent kink" is confirmed.A kink to the central lumen was noted during the visual inspection of the returned iab catheter, and a guidewire could not pass successfully through the iabc central lumen during functional testing.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 kinked central lumen.The root cause of the kinked central lumen is undetermined, but a most probable potential root cause is user related.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "suspected internal permanent kink".The report states that after insertion of the iab, pumping was started but the iabp immediately alarmed for "possible helium loss 3 alarm".The bpw appeared with severely widened inflation and deflation artifact.The balloon volume was decreased first to 35cc and then to 30cc.This did not resolve the issue and as a result, the iab was removed and a 2nd iab was inserted at the same insertion site with minimal interruption in therapy.The patient is being well supported by the pump.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• 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: 17342240
• MDR Text Key: 319375109
• Report Number: 3010532612-2023-00390
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• 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,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F23A0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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
• Treatment: N/A.; N/A.; N/A.
• Patient Sex: Male