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

Model Number	ASDS-14F-075
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	11/23/2022
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, a 14f amplatzer steerable delivery sheath was selected for procedure to implant a 16 amplatzer amulet left atrial appendage occluder.It was noted that there was a tombstone like change on the intra-operative electrocardiogram due to st elevation, but no myocardial infarction was reported.All the sequences of events for the procedure had been performed according the the instructions for use.Patient was hemodynamically stable up until the st elevation noted.It was also noted that the patient's blood pressure became unstable.The patient's blood pressure dropped to 59/29, resulting in bradycardia.The patient was administered epinephrine to mitigate their low blood pressure.A echocardiogram was performed and discovered air in the patient's left atrium and left ventricle.Only aspiration done was while evacuating air out of the left atrium and left ventricle.The air was evacuated from the patient using a 50cc syringe connected to the back of a 110cm pigtail to under fluoroscopic and transesophageal echocardiogram guidance.It was noted after removal of the air from the patient that the patient's heart rate increased, but left ventricular function decreased.The patient was then administered dopamine due to becoming hypertensive (blood pressure = 204/103).The patients left ventricle did not recover to normal function.Arterial line access was initiated.A continuous flush of saline through the flushing port maintained throughout the procedure.Contrast had been injected through the manifold which was connected to the luer, attached to the device system.After administering dopamine the patient's blood pressure dropped to 97/51, in which case the patient was administered levophed and their blood pressure stabilized to 140/80.The patient was admitted to the intensive care unit for monitoring of their condition.The procedure was delayed due to the admiration of medication, arterial line obtained, and evacuation of air from the left atrium and left ventricle.On 24 november 2022, the patient was stable and discharged without further complications.There was no visible leak found on the delivery system.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the patient had been placed under general anesthesia for procedure.The syringe was attached to the hemostasis valve when aspirating/evacuating the air embolus.There was a total of 2 separate saline drips one going through the side port, and one through the manifold of the three way stop cock.The patient had been administered heparin and the patient's activated clotting time levels were around 250 seconds.The bypass valve remained closed throughout the procedure.The trans-septal puncture had been performed non-abbott needle and placed a non-abbott 8.5f catheter into the left atrium under transesophageal echocardiographic and fluoroscopic guidance.
Additional Manufacturer Narrative
An event of st elevation, low blood pressure, air in patient's left atrium and left ventricle, hypertension was reported.A returned 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.Based on the information received, cause of reported event could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 device code 1751 removed.

• 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: 16010205
• Report Number: 2135147-2022-02646
• Device Sequence Number: 5620179
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8448121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female