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

Model Number	ASDS-14F-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
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 the product met all specifications.Although no air embolus was observed, it is important to note that abbott has identified air embolism as a potential illness or injury.Customers have reported air emboli having resulted in transient st segment elevation resolving spontaneously and, less commonly, hemodynamic instability requiring medical intervention.The capa (action 132620) investigation has confirmed that the asds integrated hemostasis valve design and procedural use allow for air to ingress when optimal air management techniques are not adhered to by physicians.As a result of this finding, abbott is performing further investigation to monitor this issue.Na.
Event or Problem Description
It was reported that on (b)(6) 2022, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer steerable delivery sheath.The patient was under general anesthesia during the procedure.A continuous flush was attached to the side port of the delivery sheath.When the delivery sheath was introduced to the patient and after the guidewire was removed, the patient noted to have st segment elevation.There was no excessive resistance or difficulty noticed when the delivery system was introduced to the patient.The st elevation resolved without intervention after a few minutes, and the procedure was continued.No air embolus was observed in the patient.St elevation was noted again after the amulet occluder was inserted through the delivery sheath.There was no excessive resistance or difficulty noticed when the device was passed through the delivery sheath.No aspiration was done on the delivery sheath.The patient's vital signs were stable, and the st elevations resolved again without intervention.The amulet occluder was implanted successfully.There was no clinically significant delay in the procedure.The patient was reported as stable and discharged.No additional information was provided.

• 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: 17149498
• Report Number: 2135147-2023-02635
• Device Sequence Number: 3893190
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 8448549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/18/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2135147-6/8/23-001-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMULET LAA OCCLUDER, 9-ACP2-007-022, 8559617.
• Patient Age: 59 YR
• Patient Sex: Female