MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN917531

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the intra-aortic counterpulsation balloon did not work properly, the 'yellow cap' normally integrated into the remove part remained attached to the balloon.So it was impossible to remove it.The counterpulsation balloon had to be changed, so new kit had to be used and opened".The 2nd iab was inserted successfully.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).The reported complaint that the " 'yellow cap' normally integrated into the remove part remained attached to the balloon" was confirmed based on the returned state of the device.The customer returned a 30cc 8.0fr fos intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in a cardboard box and was in a sealed bio-hazard bag (inp-1, inp-2).Returned with the sample was the supplied long ap tubing; no damage or abnormality was noted to the tubing (inp-5).One of the packaging retention sleeves was noted on the iabc bladder; the distal end of the retention sleeve was noted at approximately 4.1cm from the iabc distal tip (inp-4, inp-7).The exposed portion of the bladder was fully unwrapped (inp-7).The one-way valve was tethered to the short driveline tubing (inp-6).Some spots of dried blood were noted on the exterior of the returned sample; no blood was no ted 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 (inp-8, inp-9, and inp-10).The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact.No damage was noted to the cal key.No original packaging was returned with the sample; therefore, it cannot be determined if any original packaging tray issues caused difficulty removing the iabc from its tray.The packaging retention sleeve was noted on the bladder membrane upon receipt, which could indicate a potential that the catheter was not prepped per the instructions for use (ifu): "1.Connect one-way valve to male luer on short driveline tubing attached to iab.Insert supplied syringe into one-way valve.Slowly aspirate a full syringe of air.Precaution: the one-way valve will maintain vacuum on the balloon and must remain in place until is fully inserted.Remove syringe.2.Remove catheter from tray, keeping it in line with balloon membrane.3.Grasp catheter close to tray and pull it straight out of the holding sleeve.Note: keep catheter level with tray.Do not lift or bend during removal." the bladder thickness was measured at six points with measurements ranging from 0.0063in-0.0067in and was within specification of process document.The one-way valve was tested and pa ssed.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 cal key and fos were connected to the iabp.The cal key was recognized (anp-1).The cal key was disconnected and re-connected again after rotating the cal key 180 degrees; the cal key was recognized again.The pump status displayed "ll" low light and "pl" pressure limit, indicating a possible broken fiber (anp-2).The fos fiber was found broken approximately 1.2cm from the iabc distal tip (anp-3).No other fiber breaks were noted.The iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.A vacuum was pulled on the iabc using the returned one-way valve.While maintaining a vacuum, the retention sleeve was moved from the bladder and towards the bifurcate without difficulty.The bladder and retention sleeve were visual inspected, and no damage or abnormalities were noted (anp-4).The iabc was leak tested in accordance with testing methods from manufacturing procedure.No leaks were detected.Full inflation was achieved.The device passed the leak test.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the i abc luer.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.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 retention sleeve on the iabc.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "the intra-aortic counterpulsation balloon did not work properly, the 'yellow cap' normally integrated into the remove part remained attached to the balloon.So it was impossible to remove it.The counterpulsation balloon had to be changed, so new kit had to be used and opened".The 2nd iab was inserted successfully.At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17899912
• MDR Text Key: 325461262
• Report Number: 3010532612-2023-00575
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: IPN917531
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F22A0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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
• Treatment: N/A.; N/A.