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	Bradycardia (1751); Non specific EKG/ECG Changes (1817)
Date of Event	01/20/2023
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) 2023, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.The delivery sheath was prepared per the ifu and a pressure bag of heparin saline was connected to it.Before the device was inserted into the sheath, the pigtail catheter was being advanced when air was noted in the device.Then, the patient had st elevations and bradycardia.The patient was extubated.After the patient stabilized, the device was implanted successfully using a 12f amplatzer torqvue 45x45 delivery sheath in a separate procedure.The patient was reported as stable and was discharged the following day.No additional information was provided.
Event or Problem Description
Subsequent to the information filed, to treat the air embolus, the patient was treated with 100% oxygen and a cardiac catheterization was performed to check the coronaries.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, b6, g3, h2, h6na.
Additional Manufacturer Narrative
An event of an air being observed in the sheath 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.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, the cause of the reported incident could not be conclusively determined.

• 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: 16376236
• Report Number: 2135147-2023-00520
• Device Sequence Number: 6142205
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/18/2023

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: 01/20/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 04/18/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/08/2023; 04/18/2023
• 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: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female