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

Catalog Number	STRBL-14F-075
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
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 a 25mm amplatzer amulet left atrial appendage occluder was selected for a procedure on (b)(6) 2024 using a 14f amulet steerable delivery sheath.The devices were prepared per ifu.During the procedure, the device was partially recaptured twice as the device was not coaxial in the laa during those deployments.The device was released from the delivery cable upon the third deployment.Upon removal of the delivery sheath from the patient, the tip of the delivery sheath was observed to have split and was nearly broken off.The patient had no tortuous anatomy.There was no difficulty inserting the delivery sheath into the patient nor was there difficulty advancing the delivery sheath through the patient anatomy.No damage was visible on the delivery sheath prior to removal from the patient.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
It was reported that the tip of the delivery sheath was observed to have split and was nearly broken off upon removal from the patient.Information from field indicated that the patient had tortuous anatomy; and that the device was partially-recaptured twice as the device was not coaxial in the laa during those deployments.Field also indicated that there was no difficulty inserting the delivery sheath into the patient nor was there difficulty advancing the delivery sheath through the patient anatomy.No adverse patient effects were reported.A returned device assessment could not be performed as the device was not returned for analysis.Three images from field appeared to show split at the tip of sheath, confirming reported event.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 related complaints associated with any other devices from the lot.Cross functional teams at abbott reviewed the reported details and deemed the reported event was related to a potential product quality issue.As a result of this finding, the reported event is under further investigation per internal procedures.

• 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# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20217553
• Report Number: 2135147-2024-04509
• Device Sequence Number: 7900614
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)241031(10)10097388
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/25/2024

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: 10/31/2024
• Device Catalogue Number: STRBL-14F-075
• Device Lot Number: 10097388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• 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
• Patient Sex: Unknown