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

Model Number	ASDS-14F-075
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature attachment: percutaneous left atrial appendage closure with superior vascular access case study.As reported in a research article, an event of cardiac tamponade was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
The article, "percutaneous left atrial appendage closure with superior vascular access", was reviewed.The research article presents a case study of a 62 year old male who required a left atrial appendage closure (laac) due to recurrent strokes despite being on anticoagulation.Percutaneous vascular access through the left axillary vein was attempted.The transseptal puncture was performed at the infero-posterior part of the fossa ovalis with the a non-abbott wire/sheath (supracross rf).A transseptal puncture system consisting of a steerable sheath and radiofrequency wire with a flexible, spiral tip, to obtain access to the left atrium.After gaining left atrial access, an amplatzer steerable delivery sheath (asds) was delivered into the left atrium.However, due to the superior access used in this procedure, the alignment of the asds with the main axis of the laa was possible only after deflecting the distal articulation of the asds.A 31 mm amplatzer amulet device was then successfully released after confirming proper device placement using both fluoroscopy and echocardiography.A pericardial tamponade was noted, a probable consequence of the high force applied on the asds during the device delivery, was successfully aspirated without sequelae.The vascular access site was then closed with a z-shaped suture.At 45 days, no events were reported and the computed tomography scan showed a good position of the device with good laa-device alignment.The article concluded that coaxial alignment of the delivery sheath with the laa axis is crucial to achieve good laa sealing and device stability during percutaneous laac.[the primary author of this article is roberto galea, md, department of cardiology, inselspital, bern university hospital, university of bern, bern, switzerland, the correspondence author is lorenz räber, md, cardiology department, bern university hospital, freiburgstrasse 18, ch-3010, bern, switzerland, with e-mail: lorenz.Raeber@insel.Ch].

• 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: 17036207
• Report Number: 2135147-2023-02392
• Device Sequence Number: 6459857
• Product Code: DQY
• UDI-Device Identifier: 05415067036025
• UDI-Public: 05415067036025
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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 Model Number: ASDS-14F-075
• Device Catalogue Number: ASDS-14F-075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Male