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

Catalog Number IAB-06840-U

Device Problem Break (1069)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The report states that the "user implanted the iab catheter into patient follow instruction of use.After 5 minutes, user found out the helium gas tubing had blood, they removed the iab catheter and replaced by another arrow iab catheter to continue the therapy.User found that the distal tip of wire-reinforced catheter body was fracture".Additional information received states that the fractured part of the catheter remained in the balloon portion.No piece was left in the patient and all pieces were accounted for.A new 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).The reported complaint of iab blood in helium pathway was confirmed upon 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 cardboard box and was in a sealed ziploc bag (inp-1, inp-2).Upon return, the iabc central lumen within the flex-tip assembly area was immediately noted damaged; the wire round/polyimide (part of the flex tip assembly) was noted no longer attached and separated from the inner cannula (iabc central lumen) at approximately 7cm from the iabc distal tip (inp-7).The one-way valve including one-way valve tether was not returned with the sample.The bladder was fully unwrapped (inp-6).A bend to the iabc central/outer lumen was noted at approximately 50.6cm from the iabc luer end (inp-8).A stat-lock stabilization device was noted on the hemostasis cuff; an unknown dried substance was noted on the stat-lock stabilization device (inp-5).Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was also noted within the iabc helium pathway.The iabc appeared to have been cleaned prior to return.No other visual damage or abnormalities were noted to the returned sample.An attempt to aspirate and flush the iabc central lumen using a 60cc lab-inventory syringe was unable to be successfully completed as part of functional inspection.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 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 consistent with the previously confirmed damaged/separated central lumen (inp-7).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.The guidewire exited the central lumen and entered the bladder at the location of the flex-tip assembly separation.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 50.7cm from the iabc luer, which is the location of the previously noted bend.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.Capa has been initiated under teleflex's quality system by the manufacturing site to address this complaint issue.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 the "user implanted the iab catheter into patient follow instruction of use.After 5 minutes, user found out the helium gas tubing had blood, they removed the iab catheter and replaced by another arrow iab catheter to continue the therapy.User found that the distal tip of wire-reinforced catheter body was fracture".Additional information received states that the fractured part of the catheter remained in the balloon portion.No piece was left in the patient and all pieces were accounted for.A new 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 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: 18402867
• MDR Text Key: 331502277
• Report Number: 3010532612-2023-00732
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 18F23G0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• 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