MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Catalog Number 9-ACP2-010-025

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that a 25mm amplatzer amulet left atrial appendage occluder was selected for a procedure on (b)(6)2024 using a 14f amulet steerable delivery sheath.The patient's activated clotting time was 266.During implant foreign material was noted on the lobe of the device upon removal from the delivery sheath.The device was re-captured and removed from the patient.Upon inspection fabric was noted on the lobe.The patient did not present with any clinical signs or symptoms.There were no adverse effects to the patient.The patient status was stable.

Manufacturer Narrative

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

• Brand Name: AMPLATZER AMULET
• Type of Device: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19044728
• MDR Text Key: 339433215
• Report Number: 2135147-2024-01551
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: (01)00811806013497(17)270430(10)8496840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 8496840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2022
• 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: 14F AMPL AMU DS [STRBL-14F-075, LOT: 10027494]