MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after insertion and initiation of iabp therapy, blood was found in the helium pathway, as a result the iab was removed.A 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "unknown".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

Qn#(b)(4).Additional information received on 18 oct 2023 states the current status of the patient is "fine".The reported complaint that the "blood was found in the helium pathway" was confirmed based on the investigation of the returned sample.The customer returned a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that does not match the serial number of the returned sample (inp-3, inp-4) for investigation.The sample was returned in a cardboard box and was loosely packed within the original packaging carton/tray (inp-1, inp-5).Returned with the sample was the supplied kit components including 40cc inflation driveline tubing, teflon sheath and short arterial pressure tubing.The returned teflon sheath with the sample was appeared used; dried blood was noted within the interior surfaces of the sheath extrusion and liquid blood was noted within the sidearm (inp-7, inp-9).The one-way valve was tethered to the short driveline tubing (inp-10).The bladder was fully unwrapped (inp-11).The iabc central lumen within the flex-tip assembly area was noted damaged; the wire round/polyimide (part of the flex tip a ssembly) was noted separated and no longer attached to the inner cannula (iabc central lumen) at approximately 6.7cm from the iabc distal tip (inp-16).The iabc central lumen was noted kinked at approximately 5.8cm from the iabc distal tip (inp-16).A bend to the iabc was noted at approximately 30.5cm, 42.5cm, and 51.8cm from the iabc luer (inp-13, inp-14, inp-15).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was also noted within the iabc helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0053in-0.0062in 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 q-96 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 flex-tip assembly was separated; however, the catheter's central lumen was still able to be aspirated and flushed using a 60cc lab-inventory syringe.No debris was noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.A leak was immediately detected from the iabc distal tip and iabc luer end (anp-1, anp-2).The leak from the iabc distal tip and iabc luer end are c onsistent with the previously confirmed damaged central lumen (inp-16, anp-3, abp-4).The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.8cm from the iabc distal tip, which is the location of the previously noted kink.Upon further advancing the guidewire into the iabc central lumen, the shrink tube from the flex-tip assembly became completely separated from the inner cannula (anp-5, anp-6) and the guidewire entered the bladder at the location of the shrink tube/flex-tip assembly separation.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 23.4cm, 43cm and 53.4cm from the iabc luer, which are the locations of the previously noted bends.The guidewire then exited the central lumen and entered the bladder at the location of the inner cannula separation.No blood or debris was noted.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 damaged central lumen.The root cause of the complaint was undetermined.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that after insertion and initiation of iabp therapy, blood was found in the helium pathway, as a result the iab was removed.A 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "unknown".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: ULTRAFLEX IAB: 7.5FR 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17923806
• MDR Text Key: 325830936
• Report Number: 3010532612-2023-00577
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23G0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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: 59 YR
• Patient Sex: Male