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

Model Number	ASDS-14F-075
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	02/06/2023
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 patient was placed under general anesthesia for the duration of the procedure.After the steerable sheath was in position in the left atrium and the pigtail catheter was in the left atrial appendage, but before the device was inserted, a st segment elevation was observed.Air was visualized in the patient via echocardiography images of the anterior left ventricle.The ejection fraction was noticed to be decreased.Catheterization of the left heart was completed.After 3-4 minutes the st segment returned to baseline and was resolved after 8 minutes.The air embolism resolved, and ejection fraction also returned to baseline after 8 minutes.The amulet device was successfully implanted after the catheterization and the st elevations were resolved.There was a delay in the procedure, however no serious injury occurred.The patient was reported as stable.No additional information was provided.
Additional Manufacturer Narrative
An event of air embolism and st elevations were 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 that the product met all specifications.A capa was initiated for further investigation on the amplatzer steerable delivery sheath air ingress trend, per internal procedures.

• Brand Name: AMPLATZER STEERABLE DELIVERY SHEATH
• 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: 16470184
• Report Number: 2135147-2023-00957
• Device Sequence Number: 17409249
• 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): 05/31/2023

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: 07/31/2023
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8601676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 100 KG