MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-PFO-2518

Device Problem Air/Gas in Device (4062)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2024, a 18-25mm amplatzer talisman patent foramen ovale (pfo) occluder (lot: 8864459) was chosen for implantation utilizing an 8f amplatzer talisman delivery sheath.During preparation, when attempting to advance the occluder into the delivery sheath, air bubbles appeared in the loader.Only when all connections, from the sheath to the loader, from the loader to the hemostasis valve, and the hemostasis valve were submerged in a water bath, could the device be advanced without bubbles.No air entered the patient anatomy.No additional aspiration was needed to prevent air from entering the patient anatomy.The device was implanted successfully.There were no reported patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout.

Manufacturer Narrative

An event of air bubbles appeared in the loader when attempting to advance the occluder into the delivery sheath was reported.Also reported that only when all connections from the sheath to the loader, from the loader to the hemostasis valve, and the hemostasis valve were submerged in a water bath, the device could be advanced without bubbles.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of air in loader device could not be conclusively determined.Information from field indicated that no air entered the patient anatomy and that the device was implanted successfully.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18826707
• MDR Text Key: 336851468
• Report Number: 2135147-2024-00955
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)251231(10)8864459
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 8864459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2023
• 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