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

Catalog Number IAB-06840-U

Device Problem Difficult to Remove (1528)

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

Event Date 09/16/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent iabp implantation due to emergency arrhythmia, arrhythmia electrical storm, and respiratory and cardiac arrest.The catheterization was completed at 23:30 on (b)(6) 2023, the iabp worked normally before being sent to the icu.At 06:58 on (b)(6) 2023, the iabp suddenly stopped working.The catheter was removed and the doctor found it was difficult to remove, considering the risk, the doctor contacted interventional vascular surgery for consultation to remove the balloon.After undergoing femoral artery opening surgery, the balloon was successfully removed, and the patient returned to the icu in good condition.Another iab was not inserted.No patient harm or injury.The patient status is reported as "fine".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).Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).The additional information received on 17oct2023 reported that anticoagulants were administered prior to the procedure.The procedure was a single successful attempt and the iab catheter ruptured when it was surgically removed.The patient condition was fine post-surgery.The reported complaint for iab blood in helium pathway was confirmed based upon the investigation of the returned sample.The customer returned a 40cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging for investigation.The sample was returned in a brown cardboard box within a yellow bio-hazard bag (inp-1, inp-2).Upon return, the distal end of the teflon sheath was at approximately 44.4cm from the iabc distal tip (inp-4).The teflon sheath was noted connected to the hemostasis cuff (inp-4, inp-5).A non-teleflex 60 ml syringe was inserted to the one-way valve; blood was noted within the syringe (inp-5).The one-way valve was tethered and connected to the short driveline tubing (inp-5).The supplied arterial pressure tubing was connected to the iabc luer; clear fluid was noted within the tubing (inp-5).The iabc bladder was fully unwrapped (inp-6).The iabc central lumen was noted broken within the flex-tip assembly area at approximately 6cm from the iabc distal tip (inp-7).Bends to the iabc central lumen were noted at approximately 16cm, 41.8cm, and 68.4cm from the iabc distal tip (inp-6, inp-8, inp-9).Dried blood was noted on the exterior surfaces of the returned sample.Dried blood was noted within the bladder/helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0058in-0.0064in 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.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed.Upon aspiration, water was unable to be consistently pulled into the syringe.The attempt to flush resulted in bladder inflation.The results are consistent with the previously noted damaged central lumen (inp-7).The iabc was leak tested in accordance with testing methods from manufactu ring procedure.Three leaks were immediately noticeable from the bladder membrane (anp-1).Under microscopic inspection, the leak sites are consistent with contact from a sharp object and were noted at approximately 24.6cm, 24.7cm and 25.6cm from the iabc distal tip (anp-2, anp-3, anp-4).Based on the event details, the leak sites consistent with contact from a sharp object likely occurred after removal of the device and the broken central lumen in the flex tip assembly was the most likely cause of the blood in the helium pathway.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.The guidewire met resistance and could not advance at approximately 3.9cm from the iabc distal tip due to a blocked central lumen.Some blood was noted on the guidewire.The central lumen was likely blocked by dried blood.The guidewire was front loaded through the iabc luer.The guidewire met resistance and could not advance at approximately 40.2cm from the iabc luer due to a blocked central lumen.Some blood was noted on the guidewire.The central lumen was likely blocked by dried blood.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 broken 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.

Event Description

It was reported that the patient underwent iabp implantation due to emergency arrhythmia, arrhythmia electrical storm, and respiratory and cardiac arrest.The catheterization was completed at 23:30 on (b)(6) 2023, the iabp worked normally before being sent to the icu.At 06:58 on (b)(6) 2023, the iabp suddenly stopped working.The catheter was removed and the doctor found it was difficult to remove, considering the risk, the doctor contacted interventional vascular surgery for consultation to remove the balloon.After undergoing femoral artery opening surgery, the balloon was successfully removed, and the patient returned to the icu in good condition.Another iab was not inserted.No patient harm or injury.The patient status is reported as "fine".

• 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: 17924407
• MDR Text Key: 325529691
• Report Number: 3010532612-2023-00584
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23E0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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
• Treatment: N/A.; N/A.
• Patient Age: 49 YR
• Patient Sex: Male