MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/23/2023

Event Type  malfunction  

Event Description

The report states that after a successful insertion, blood was found in the helium pathway.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(b)(4).The reported complaint that "blood was found in the helium connecting tube" is confirmed based on the visual inspection of the returned sample.The customer returned for investigation was a 30cc 7.5fr ultra flex intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box within a black bag (inp-1, inp-2).Returned with the sample was the supplied data-scope inflation tubing; dried blood was noted within the inflation tubing (inp-4, inp-7).Upon return, the one-way valve was tethered to the short driveline tubing (inp-5).The bladder was fully unwrapped (inp-6).The iabc was noted with a "u" shaped bend in the location of the entire bladder section (inp-6).Some portion of the iabc distal tip was noted within the iabc bladder near the distal end of the bladder (inp-8).The iabc flex-tip assembly (part of the iabc central lumen) was separated and no longer attached to the iabc distal tip (inp-8).The iabc central lumen within the flex-tip assembly area was noted damaged (inp-9).The supplied 0.025in guidewire was noted fully inserted within the iabc central lumen; the guidewire exited the central lumen and entered the bladder at the location of the distal tip separation (inp-4, inp-5, and inp-8).Damage to the outer lumen was noted from approximately 48.5cm to 51cm from the iabc luer (inp-10).Bends to the iabc were noted at approximately 24.2cm, 45.1cm, and 53.5cm from the iabc luer (inp-11, inp-12, inp-13).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.No sheath was returned with the iabc.The bladder thickness was measured at six points with measurements ranging from 0.0062in-0.0066in 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 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 returned guidewire was removed from the iabc central lumen; some blood was noted on the guidewire.The catheter's central lumen was unable to be aspirated and flushed due to the returned state of the sample.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip (anp-1).The leak from the iabc distal tip is consistent with the previously confirmed damaged central lumen (inp-8, inp-9, anp-3).The iabc was leak tested again with the iabc distal tip blocked off; another leak site was immediately detected from the bladder membrane (anp-2).Under microscopic inspection, the leak site was confirmed at approximately 10.2cm from the iabc distal tip and was consistent with the contact from a sharp object (anp-4, anp-5).Due to the combined damages, it could not be confidently determined which damage occurred first or what initially caused the blood to enter the helium pathway.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 blood in the helium pathway.The root cause of how the blood entered the helium p athway was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

The report states that after a successful insertion, blood was found in the helium pathway.As a result, the iab was removed and a 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: 18367111
• MDR Text Key: 331063151
• Report Number: 3010532612-2023-00727
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F23K0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG