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

Catalog Number	9-ACP2-007-016
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event of cracked stopcock was reported.It was also reported that air was visible on fluoroscopy in the delivery sheath.A return device assessment 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.How or when the damage occurred could not be conclusively determined, however it is consistent with damage during use.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that a 18mm amplatzer amulet left atrial appendage occluder (lot 8553355) was selected for implant on (b)(6) 2023 using a 12f amplatzer torqvue 45x45 delivery sheath.It was noted to be difficult to connect the loader of the amulet occluder to the delivery sheath.The stopcock was replaced with a rotating non-abbott stopcock.The device was deployed and placed in the appendage.However, during release of the device, the device appeared to be squeeze out of the appendage and partially migrated.Since the device had not yet been fully released from the delivery cable, the device was able to be retightened and recaptured.The device was replaced with a 16mm amplatzer amulet left atrial appendage occluder (lot 8553346) using the same delivery system.The non-abbott stopcock from previous device was removed and screwed into the 16mm amplatzer amulet occluder loading system.The stopcock cracked, allowing air into the system.Air was visible on fluoroscopy in the delivery sheath.Aspiration was successfully performed.No air was visible in the patient.The patient did not have any symptoms.The device was replaced with a 16mm amplatzer amulet left atrial appendage occluder (lot 8553346), which was successfully implanted.There no reported patient consequences.

• Brand Name: AMPLATZER AMULET
• Common Device Name: 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: 18807400
• Report Number: 2135147-2024-00926
• Device Sequence Number: 7324117
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: 00811806013459
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 8553346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE 45X45 DS, 9-TV45X45-12F-080
• Patient Sex: Unknown