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

Catalog Number IAB-05850-LWS

Device Problem Inflation Problem (1310)

Patient Problem Hematoma (1884)

Event Date 09/02/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that, "balloon would not fully expand upon insertion.Md manually inflated balloon however it would still not inflate with console".As a result the iab was removed.A 2nd iab was not inserted as "access was lost" and the customer reported a "massive hematoma".The current status of the patient is reported as "unknown".At the time of this report the customer has stated there is no further information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).Medwatch#mw5145539.The serial number ((b)(6)) recorded on the complaint report matches the serial number on the returned sample.The lot number (18f22j0040) recorded on the complaint report matches the lot number for the returned sample.Returned for investigation was a 50cc 8fr fiberoptix ultra (fos) intra-aortic balloon catheter (iabc) without the original packaging.Returned with the sample was supplied 50cc inflation driveline tubing; no damage or abnormalities were noted to the returned driveline tubing.Upon return, the iabc bladder was noted withdrawn through the teflon sheath and the teflon sheath was noted on the iabc bladder membrane.The teflon sheath hub was noted at approximately 59.7cm from the iabc luer end.Buckling to the teflon sheath extrusion was noted approximately from 5.9cm to 14.8cm from the distal end of the teflon sheath.The one-way valve was tethered to the short driveline tubing.The long arterial pressure tubing was noted connected to the iabc luer; clear fluid was noted within ap tubing.The exposed portion of the bladder was fully unwrapped; the distal end of the bladder and iabc distal tip was noted within the iabc bladder membrane.Upon further inspection, the distal end of the bladder was noted separated and no longer attached to the iabc distal tip.A bend to the iabc central lumen was noted at approximately 23.5cm from he iabc luer end.A kink to the iabc central lumen was noted at approximately 59cm from the iabc luer end.Dried blood was noted on the exterior surfaces of the returned sample.Liquid blood was noted only with the iabc bladder membrane.The fos connector and cal key were examined.The fos gray connecter was recessed 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 damage was noted.The cal key was intact.Additionally, 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 correctly per the ifu.As a result, an in-service for the customer is requested to reiterate the instructions for use (ifu).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 0.0065in-0.0072in 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.The cal key and fos were connected to the iabp.The cal key was recognized.The cal key was removed and rotated 180 degrees and the cal key was recognized again, but the fos was not recognized because of the recessed fos connector.Using lab inventory forceps, the gray fos connector was held in place and the fos was recognized and zeroed by the iabp.The pump status displayed "ok" i ndicating the fiber is fully intact.The one-way valve connected to the iabc short driveline tubing, and a vacuum was pulled on the returned iabc.While maintaining the vacuum, the teflon sheath was removed from the iabc bladder and moved towards the iabc bifurcate with some force required.Upon further inspection, some damage was noted to the distal end of the bladder; the damage is consistent with being ripped/torn.The iabc distal tip was still fully intact with the central lumen.The condition of the iabc distal tip and bladder tip shows evidence of the previously laminated bond.It could not be confidently determined when the damage occurred; however, the most probable potential cause of bladder detachment from the iabc distal tip is a result of the removal technique of the iabc from the patient.The iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.Some blood was noted.The iabc was leak tested and a leak was immediately detected from the distal end of the bladder membrane.The leak from the distal end of the bladder membrane is consistent with the previously confirmed bladder detachment from the iabc distal tip.The iabc was leak tested again, with the distal tip of the bladder clamped off, and no other leaks were detected.Full inflation was achieved.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire could not advance at approximately 22.9cm from the iabc distal tip, which is the location of the previously noted kink.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 59.2cm from the iabc luer, which is the location of the previously noted kink.Some blood was noted on 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 that the "balloon would not fully expand upon insertion" is not able to be confirmed.During the investigation, there were various damages noted to the intra-aortic balloon catheter (iabc) and sheath; the iabc bladder was found withdrawn through the teflon sheath upon return.Also, the iabc distal tip was no longer attached to the catheter bladder.Due to the damages and returned state of the device, it could not be confidently determined when the damages occurred (i.E., during therapy, during device removal or after the device was removed).An in-service has been requested to review the instructions for use (ifu) with the customer since the returned iabc bladder was found withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion.This indicates the iabc was not removed per the instructions for use (ifu) and could result in damage to the device.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermi ned.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that, "balloon would not fully expand upon insertion.Md manually inflated balloon however it would still not inflate with console".As a result the iab was removed.A 2nd iab was not inserted as "access was lost" and the customer reported a "massive hematoma".The current status of the patient is reported as "unknown".At the time of this report the customer has stated there is no further information.If additional information is received, the complaint file will be updated.

• Brand Name: FIBEROPTIX ULTRA 8 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17732760
• MDR Text Key: 323227594
• Report Number: 3010532612-2023-00529
• Device Sequence Number: 1
• Product Code: DSP
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05850-LWS
• Device Lot Number: 18F22J0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 142 KG