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 10/02/2023

Event Type  malfunction  

Event Description

It was reported that "doctors from (b)(6) hospital found that the machine could not work after balloon implantation.After the catheter was withdrawn, it was found that the balloon ruptured, and blood was found in the balloon".Another iab was not inserted.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4) other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "doctors from (b)(6) hospital found that the machine could not work after balloon implantation.After the catheter was withdrawn, it was found that the balloon ruptured, and blood was found in the balloon".Another iab was not inserted.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "the balloon ruptured" was confirmed based on 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 cardboard box and was in a ziploc bag (inp-1, inp-2).Upon return, the distal end of the teflon sheath was at approximately 42.5cm from the iabc distal tip; a clear liquid was noted within the sheath sidearm (inp-4).The teflon sheath was noted connected to the hemostasis cuff (inp-4).The one-way valve was tethered and connected to the short driveline tubing (inp-5).The iabc bladder was fully unwrapped (inp-6).Multiple cuts were noted on the iabc bladder at approximately 2.7cm to 6.1cm and 3cm to 3.8cm from the iabc distal tip (inp-7, inp-8, inp-9).The damage to the iabc bladder appears consistent with contact from a sharp object; the tears likely occurred after removal.Bends to the iabc central lumen were noted at approximately 8.2cm, 13cm, 16cm, 19cm, 27.3cm, 31.2cm, 39.8cm, and 64cm from the iabc distal tip (inp-10 through inp-15).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 0.0061in-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.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 according to quality system document.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.Leak were immediately detected from the previously noted cuts (inp-7, inp-8, inp-9, anp-1 through anp-5).A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 5.4cm, 14.9cm, 18.1cm, and 65.9cm from the iabc distal tip, which are the locations of the previously noted bends.The guidewire met resistance and could not advance at approximately 65.9cm from the iabc distal tip.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 17.1cm, 68cm, and 77cm from the iabc luer, which are the locations of the previously noted bends/kinks.The guidewire was able to advance through the central lumen.Some blood 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 bladder leak.The root cause of the bladder leak is undetermined.The most probable potential cause of how the catheter came into contact with a sharp object is customer handling.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

• 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: 18133587
• MDR Text Key: 328980253
• Report Number: 3010532612-2023-00647
• 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: 11/07/2023

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-06840-U
• Device Lot Number: 18F23D0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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: 86 YR
• Patient Sex: Male