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

Model Number	STRBL-14F-075
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
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) 2025, a 14f amplatzer steerable delivery sheath was selected for use.During device preparation, the sheath end was not inspected, however the sheath was prepped and flushed as per normal requirements.During implant, when completing a full recapture, "a plastic band was found on the lobe of the amulet." the band is thought to have come "from the end of the steerable sheath." the delivery sheath was exchanged for a new 14f amplatzer steerable delivery sheath, which was used to successfully complete the procedure.The patient was reported to be in stable condition.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
It was reported that on during implant when completing a full recapture, a plastic band was found on the lobe of the amulet, which was thought to have come from the end of the steerable sheath.The delivery sheath was returned to abbott and the tip of the sheath was noted to be cut off.No other anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.Based on the findings, the issue appears to be related to a potential product quality issue; the issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• 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: 22091567
• Report Number: 2135147-2025-02809
• Device Sequence Number: 17879477
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)270624(10)10727056
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K250426
• 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): 06/18/2025

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 Model Number: STRBL-14F-075
• Device Catalogue Number: STRBL-14F-075
• Device Lot Number: 10727056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male