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

Model Number	ASDS-14F-075
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	02/20/2023
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, an 18mm amplatzer amulet left atrial appendage (laa) occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.After the sheath was in the laa and while the device was being deployed, st elevations were noted.The st elevations persisted for 4 minutes and resolved without intervention.The patient was reported as stable.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2023, an 18mm amplatzer amulet left atrial appendage (laa) occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.After the sheath was in the laa and while the device was being deployed, st elevations were noted.The st elevations persisted for 4 minutes and resolved without intervention.The patient was reported as stable.Subsequent to the initially filed report, the following information was received that after the transeptal puncture was performed, the steerable delivery sheath was exchanged for the transeptal sheath.A continuous flush was administered through the side port of the delivery sheath.The device was prepared and attached to the delivery sheath via a wet-to-wet connection.St elevations were noted when the device was being loaded into the delivery sheath.The device was deployed and was being positioned when the st elevations resolved without intervention.The amulet device was then successfully positioned and released from the delivery cable.There was no clinically significant delay in the procedure.The patient was closely monitored.
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.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.H6 health effect - clinical code: code 1697 removed h6 medical device problem code: code 4062 removed.

• 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: 16546543
• Report Number: 2135147-2023-01194
• Device Sequence Number: 12263926
• 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): 05/09/2023

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: 12/31/2023
• Device Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Device Lot Number: 8824607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Female