MAUDE Adverse Event Report: ABBOTT MEDICAL AMULET STEERABLE DELIVERY SHEATH; CATHETER DELIVERY SHEATH

Model Number	STRBL-14F-075
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 21 febaruary 2025, a 28mm amplatzer amulet left atrial appendage occluder was chosen for implant using an amulet steerable sheath.During procedure, the patient's activated clotting time (act) levels were above 250 once they crossed into the left side and heparin was administered.Three attempts were made to deploy the 28mm device, at that time it was fully recaptured and they were going to attempt to try a 25mm device.Once 28mm device was fully recaptured and they were evaluating appendage a circumferential effusion was noted on intracardiac echocardiography (ice).A cardiac tamponade was also noted and protamine was administered as soon as effusion was noted.A pericardiocentesis was performed at bedside and 1100cc of blood was drained.The patient remained stable after procedure; no device was deployed.The patient was reported stable.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event for patient effects of pericardial effusion and cardiac tamponade was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause for the reported pericardial effusion could not be conclusively determined.The reported cardiac tamponade was a cascading effects of pericardial effusion.The reported unexpected medical interventions were a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Codes removed: type of investigation: 4118 type of investigation not yet determined.Investigation findings: investigation conclusions: 11 conclusions not yet available.
Event or Problem Description
N/a.

• Brand Name: AMULET STEERABLE DELIVERY SHEATH
• Common Device Name: CATHETER DELIVERY SHEATH
• 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: 21632896
• Report Number: 2135147-2025-01379
• Device Sequence Number: 18029189
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)261101(10)10614022
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K232690
• 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): 04/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: STRBL-14F-075
• Device Catalogue Number: STRBL-14F-075
• Device Lot Number: 10614022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUD
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female