MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER STEERABLE DS; CATHETER, PERCUTANEOUS

Model Number	ASDS-14F-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
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, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.During the procedure, the patient had st elevations three times.The st elevations resolved without treatment after 1-2 minutes each time.There was no leak or air embolism observed in the patient.An angiogram was done to check coronary arteries and nothing abnormal was noticed.The device was successfully implanted.There was no clinically significant delay in the procedure.The patient was reported as stable.
Additional Manufacturer Narrative
An event of st elevation was reported.A returned device inspection to rule out any device-related causes could not be performed as the device was not returned for analysis.Information from the field indicated continuous flushing was done through the side port, and no aspiration was performed.Additional information from the field also indicated that the first st elevation occurred when the steerable sheath was in place, and the pigtail catheter was advanced into the left atrium.There was no leak or air embolism observed in the patient.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2022, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.During the procedure, the patient had st elevations three times.The st elevations resolved without treatment after 1-2 minutes each time.There was no leak or air embolism observed in the patient.An angiogram was done to check coronary arteries and nothing abnormal was noticed.The device was successfully implanted.There was no clinically significant delay in the procedure.The patient was reported as stable.Subsequent to the initially filed report, the following information was received that all three of the st elevations occurred when the steerable sheath was in place and the pig tail catheter was advanced into left atrium.The st elevations occurred before the amulet was implanted.

• Brand Name: AMPLATZER STEERABLE DS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16106267
• Report Number: 2135147-2023-00040
• Device Sequence Number: 7673510
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K212026
• 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,Followup
• Report Date (Section B): 03/21/2023

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 Expiration Date: 07/31/2023
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8598983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Female