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

Catalog Number	STRBL-14F-075
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 25mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2024 using a 14f amulet steerable delivery sheath.The devices were prepared per ifu.During implant it was noted that the device took on a deformed shape.The device was removed from the patient and inspected.It was observed that a small "rubber band" item was squeezing the lobe of the occluder.The device and delivery sheath were replaced with a new 25mm amplatzer amulet left atrial appendage occluder and unknown delivery sheath.There were no angulations or kinks noted in the delivery sheath.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was stable.It was unknown where the rubber band came from.It was not noted during device preparation.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that a small "rubber band" item was squeezing the lobe of the occluder.There were no angulations or kinks reported in the delivery sheath.The delivery sheath was returned to abbott and found to contain multiple kinks.The tip of sheath was detached and showed smooth fracture with low levels of plastic deformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.An image from field appeared to show a band on the lobe of amulet, confirming the reported event.Cross functional teams at abbott reviewed the reported details and deemed the reported event of sheath tip detachment was related to a potential product quality issue.A capa (action 137720) was initiated, 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: 19652063
• Report Number: 2135147-2024-03191
• Device Sequence Number: 17763273
• Product Code: DQY
• UDI-Device Identifier: 05415067049094
• UDI-Public: (01)05415067049094(17)241031(10)10091550
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/28/2024

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: 10091550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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: 14F AMULET STEERABLE[STRBL-14F-075, LOT: 10091550]
• Patient Age: 71 YR
• Patient Sex: Female