MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06850-U

Device Problem Inflation Problem (1310)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported " after the first iab did not unwrap, this iab was plaved with the same result." to continue therapy the catheter was removed and replaced in the same insertion site.The patient's current condition is reported as "fine".Please see associated mdr# 3010532612-2024-00278.

Manufacturer Narrative

(b)(4).

Event Description

It was reported " after the first iab did not unwrap, this iab was placed with the same result." to continue therapy the catheter was removed and replaced in the same insertion site.The patient's current condition is reported as "fine".Please see associated mdr# 3010532612-2024-00278.

Manufacturer Narrative

Qn#(b)(4).Returned for investigation was a 50cc 8fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging.Upon return, the distal end of the teflon sheath was at approximately 23cm from the iabc distal tip; liquid blood was noted within the sheath sidearm.The one-way valve was tethered to the short driveline tubing.The distal portion of the iabc bladder was noted wrapped (or considered twisted); the middle portion of the iabc bladder was noted fully unwrapped.Multiple bends to the iabc central lumen were noted at approximately 17cm, 35.5cm and 55.3cm from the iabc distal tip.A kink to the iabc central lumen was noted at approximately 69cm from the iabc distal tip.Dried blood was noted on the exterior surfaces of the returned sample.No obvious blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0076in-0.0077in and was within specification.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.The iabc central lumen was successfully aspirated and flushed using a 60cc lab-inventory syringe.Some blood exited.The iabc was leak tested and during the leak test, the bladder did not fully inflate.The middle portion of the bladder had inflated but the distal and proximal portion of the bladder would not fully unwrap and was consistent with being twisted.No leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.Resistance was noted at approximately 17.2cm, 35.5cm and 55.3cm from the iabc distal tip, which are the locations of the previously noted bends.The guidewire could not advance at approximately 69.3cm from the iabc distal tip, which is the location of the previously noted kink.Some blood was noted on the guidewire.The guidewire was front loaded through the iabc luer.The guidewire could not advance at approximately 12.6cm from the iabc luer, which is the location of the previously noted kink.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 that the "iab would not unwrap" is confirmed.During the investigation, the distal and proximal portion of the iabc bladder was noted twisted and the bladder would fully inflate or unwrap during functional testing.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 twisted bladder.The probable root cause of the complaint is manufacturing related.A corrective and preventive action has been initiated to further investigate the issue.

• Brand Name: ARROW ULTRAFLEX IAB: 8FR 50CC
• 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: 19216641
• MDR Text Key: 341467793
• Report Number: 3010532612-2024-00274
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: 10801902144192
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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 Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23L0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2023
• 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