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 03/11/2024

Event Type  Injury  

Event Description

It was reported "iab did not unwrap.Iab would not unwrap after pump initiation.Distal 1/3 would not unfurl.Used a second iab from getinge".Additionally it was reported that the same insertion site was not used to place the second catheter.The patient's current condition is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).Medwatch: #mw5152827.Returned for investigation was a 50cc 8.0fr ultraflex intra-aortic balloon catheter (iabc) with the original packaging box that matches the serial number on the returned sample.Upon return, the distal end of the teflon sheath was noted at approximately 19.8cm from the iabc distal tip; liquid blood was noted within the sheath sidearm.The bladder was noted wrapped (or considered twisted) at the distal end of the bladder.A bend to the iabc was noted at approximately 42.5cm from the iabc distal tip.Dried blood noted on the exterior surfaces of the iabc; no blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0075 in-0.0078 in and was within specification of process document.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 aspirated and flushed using a 60cc lab-inventory syringe.Some blood was noted.Upon receipt, the teflon sheath was noted on a section of the bladder membrane; however, there is no evidence that the user attempted to remove the iabc/bladder through the sheath.The sheath was inspected and noted undamaged.The one-way valve was connected to the short driveline tubing and vacuum was pulled on the iabc.While maintaining the vacuum, the sheath was moved from the bladder and towards the bifurcate without difficulty.No obvious damage was noted to the proximal end of the bladder.The iabc was leak tested.During the leak test, the bladder did not fully inflate.The body 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 at 5.3cm and 42.9cm from the iabc distal tip.The guidewire was able to advance through the central lumen.No blood or debris was noted.The guidewire was front loaded through the iabc luer.Resistance was noted at approximately 39.3cm from the iabc luer, which is the location of a previously noted bend.The guidewire was able to advance through the central lumen.No blood or debris was noted.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 for "iab did 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 address the issue.

Event Description

It was reported "iab did not unwrap.Iab would not unwrap after pump initiation.Distal 1/3 would not unfurl.Used a second iab from getinge".Additionally it was reported that the same insertion site was not used to place the second catheter.The patient's current condition is reported as "fine".

• 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: 19007756
• MDR Text Key: 338979837
• Report Number: 3010532612-2024-00234
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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 Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23L0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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: MAQUET CS300; MAQUET CS300
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 53 KG