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 Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
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, an unknown sized amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery system.During the procedure, a non-abbott pig-tail catheter was being positioned in the left atrial appendage (laa) with the steerable sheath.The pig-tail catheter was dropped into the left ventricle, resulting in bradycardia followed by hypotension, st elevations, and a myocardial infarction (stemi).The amplatzer steerable sheath and the pigtail catheter were removed from the left atrium.Epinephrine was administered to treat the low blood pressure and cardiopulmonary resuscitation (cpr) was conducted for about 2 minutes and stopped once the pressure had returned to normal ranges.Arterial access was attained, and the coronary arteries were assessed.There were no abnormalities noted in the coronary arteries.All devices and sheaths were removed, and the patient was transferred to the icu for monitoring.The occluder was not implanted and the procedure was aborted.The patient was reported as stable.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2022, an unknown sized amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery system.During the procedure, a non-abbott pig-tail catheter was being positioned in the left atrial appendage (laa) with the steerable sheath.The pig-tail catheter was dropped into the left ventricle, resulting in bradycardia followed by hypotension, st elevations, and a myocardial infarction (stemi).The amplatzer steerable sheath and the pigtail catheter were removed from the left atrium.Epinephrine was administered to treat the low blood pressure and cardiopulmonary resuscitation (cpr) was conducted for about 2 minutes and stopped once the pressure had returned to normal ranges.Arterial access was attained, and the coronary arteries were assessed.There were no abnormalities noted in the coronary arteries.All devices and sheaths were removed, and the patient was transferred to the icu for monitoring.The occluder was not implanted and the procedure was aborted.The patient was reported as stable.Subsequent to the initially filed report, the following information was received that: it was undetermined why the pigtail catheter dropped.The patient was discharged on (b)(6) 2022.
Additional Manufacturer Narrative
An event of bradycardia, hypotension, st elevations, and a myocardial infarction were reported.The device was returned to abbott for investigation and the device met visual specifications when analyzed, with no anomalies being found to any components.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that this event occurred after the pigtail catheter dropped into the left ventricle during the attempt to get to the left atrial appendage.It was unknown if any air embolism occurred, no loose connections or a leak were found on the steerable sheath and there was no allegation against the steerable sheath.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 16045627
• Report Number: 2135147-2022-02718
• Device Sequence Number: 4925053
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8376344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 03/18/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male