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

Catalog Number IAB-05830-LWS

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

Reported as, "failed iab, rust specs observed in gas tubing".As a result, the iab was removed.A 2nd iab was not inserted as iabp therapy was no longer needed.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The reported complaint for iab blood in helium pathway was confirmed upon the investigation of the returned sample.The customer returned a 30cc 8fr fiberoptix ultra intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in the supplied return kit and was in a sealed bio-hazard bag (inp-1, inp-2).Upon return, the distal end of the teflon sheath was at approximately 32.9cm from the iabc distal tip (inp-7).The one-way valve was noted tethered to the short driveline tubing (inp-5).The iabc bladder was fully unwrapped (inp-6).Bends to the iabc central lumen were noted at approximately 34.5cm and 53.1cm from the iabc distal tip (inp-8, inp-9).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the iabc 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-10, inp-11, and inp-12).The center post of the fos was centered.The blue clamshell housing was examined, and no abnormalities were noted.The cal key was intact (inp-13, inp-14).The bladder thickness was measured at six points with measurements ranging from 0.0056in-0.0064in 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 according to quality system document.The cal key and fos were connected to the iabp.The fos was recognized and zeroed by the iabp (anp-1, anp-2).The pump status displayed "ok" indicating the fiber is fully intact (anp-3).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.A leak was immediately detected from the bladder membrane (anp-4).Under microscopic inspection, abrasions were observed from approximately 20.1cm to 20.8cm from the iabc distal tip (anp-5).A full thickness abrasion to the bladder was confirmed at approximately 20.4cm from the iabc distal tip and the appearance was consistent with repeated contact with calcified plaque on the aortic wall (anp-6).No other 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 52.8cm from the iabc distal tip, which is the location of the previously noted bend.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 23.2cm from the iabc luer, which is the location of the previously noted bend.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 bladder leak.The root cause of the bladder leak was related to patient condition.No further action required at this time.Teleflex will continue to monitor and trend for complaints of this nature.Other remarks: n/a corrected data: n/a.

Event Description

Reported as, "failed iab, rust specs observed in gas tubing".As a result, the iab was removed.A 2nd iab was not inserted as iabp therapy was no longer needed.No patient harm or injury.The patient status is reported as "fine".

• 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): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18003698
• MDR Text Key: 326488606
• Report Number: 3011137372-2023-00236
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F21L0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• 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
• Patient Age: 80 YR
• Patient Sex: Female