MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GUIDEWIRE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	03/10/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022 the patient underwent an implant of a 20mm amplatzer amulet left atrial appendage occluder for a left atrial appendage (laa) closure procedure.During the procedure a the procedure was completed successfully and the occluder was performing as intended.The night of (b)(6) 2022, the patient developed issues with their blood pressure.Transesophageal echocardiogram (tee) revealed that the patient had a pericardial effusion leading to tamponade.A pericardiocentesis was immediately performed but the bleeding was uncontrolled.The patient was sent to open heart surgery at a different hospital.During the surgery, a hole was found in the laa.After the surgical procedure, the patient was closely observed.Two days post surgical procedure, the patient passed away due to multi-organ system failure.It was thought that the laa was perforated using the amplatzer guidewire prior to the occluder placement.There are no allegations against the 20mm amplatzer amulet occluder.
Additional Manufacturer Narrative
An event of pericardial effusion leading to tamponade, a hole found in the left atrial appendage (laa), and patient death was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined, but is consistent with the guidewire puncturing a hole in the cardiac tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.

• Brand Name: AMPLATZER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 14313821
• Report Number: 2135147-2022-00244
• Device Sequence Number: 5373521
• Product Code: DQX
• UDI-Device Identifier: 00811806010724
• UDI-Public: 00811806010724
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: GUIDEWIRE
• Device Catalogue Number: 9-GW-002
• Device Lot Number: 9941415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female