MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000253

Device Problem Material Rupture (1546)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after insertion of the iab in the left axillary site, the balloon ruptured as blood was noted in the helium tubing.As a result, the catheter was removed and a 2nd catheter was inserted at the femoral site.No patient harm or injury as "patient tolerated procedure without any complications.".

Manufacturer Narrative

(b)(4).The serial number (lh10065) recorded on the complaint report matches the serial number on the returned sample.Returned for investigation was a 30cc 8.0fr ultra intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in the cardboard box and was in a sealed zip bag.Upon return, the one-way valve was tethered to the short driveline tubing.The supplied data-scope inflation driveline tubing was noted connected to the iabc short driveline tubing; liquid blood was noted within the returned inflation driveline tubing.The arterial pressure tubing assembly was noted connected to the iabc luer; liquid blood was noted within the ap tubing.The bladder was fully unwrapped.Upon further inspection of the iabc bladder revealed that the iabc bladder is no longer attached and separated from the iabc distal tip; no damage or abnormalities were noted to the distal tip of the bladder.The iabc central lumen was noted broken within the flex-tip assembly area at approximately 6.0cm from the iabc distal tip.The central lumen was also noted broken near the iabc bifurcate at approximately 10.4cm from the iabc luer end.A bend to the iabc central lumen was noted at approximately 20.5cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned iabc.Dried/liquid blood was noted within the iabc helium pathway.Additionally , according to the complaint report, the iabc insertion type was stated as "sheathed" insertion; however, no sheath was noted on the iabc upon receipt of the sample.This indicates that the user may have withdrawn the iab catheter through the sheath, which could have potentially resulted in iabc bladder separation from the iabc distal tip and/or damage to the iabc central lumen within the flex-tip assembly.The bladder thickness was measured at six points with measurements ranging from 0.0054in-0.0060in and was within specification of process document 13-0224 and 13-0218.The one-way valve was tested and 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 q-96.An attempt to aspirate and flush the iabc central lumen using a 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 the bladder inflation and leak from the iabc short driveline tubing.The results are consistent with the previously noted damaged/broken central lumen.A leak was immediately detected from the distal tip of the bladder membrane.The leak was consistent with the previously noted iabc bladder separation from the iabc distal tip.The iabc was leak tested again, with the distal tip of the bladder slid over the iabc distal tip and held in place; a leak was immediately detected from the iabc distal tip and iabc luer end.The leak from the iabc distal tip and iabc luer end are consistent with the previously confirmed damaged/broken central lumen.The iabc was leak tested again with the iabc distal tip and iabc luer end blocked off; no other leaks were detected.It could not be confidently determined which damage occurred first or what initially caused the blood to enter the helium pathway.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 previously noted central lumen break within the flextip assembly area.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 10.5cm from the iabc luer, which is the location of damaged/broken central lumen.Some blood was noted on the guidewire.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of iab leak suspected is confirmed.Upon return, blood was confirmed within the helium pathway.During the investigation, the intra-aortic balloon catheter (iabc) was noted with various damages, including a broken central lumen at two different locations and damage to the iabc bladder at the distal tip.Due to the combined damages and returned state of the device, 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 within the helium pathway.The root cause of how the blood entered the helium pathway is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that after insertion of the iab in the left axillary site, the balloon ruptured as blood was noted in the helium tubing.As a result, the catheter was removed and a 2nd catheter was inserted at the femoral site.No patient harm or injury as "patient tolerated procedure without any complications.".

• Brand Name: ULTRA 8 IAB: 8FR 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17293335
• MDR Text Key: 318751592
• Report Number: 3010532612-2023-00378
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902010742
• UDI-Public: 00801902010742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

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 Expiration Date: 10/31/2023
• Device Model Number: IPN000253
• Device Catalogue Number: IAB-05830-U
• Device Lot Number: 18F21L0054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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: 25 YR
• Patient Sex: Male