MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PICCOLO; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	OCCLUDER
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
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) 2023, a 5mm/4mm amplatzer piccolo occluder was chosen for implant using 5f amplatzer torqvue lp delivery system for an 18 month old, 3 lb patient.During device preparation, it was reported that the device was properly prepared per ifu by rotating occluder counter-clockwise 1/8 of one turn to facilitate device release upon deployment.During advancement of the device through the delivery sheath, the cable became detached from the device.When the device was advanced out of the delivery sheath, the embolized and traveled to the main pulmonary artery without causing any obstruction of blood flow.The device was retrieved via transcatheter snare and then implanted.The patient did not experience any clinical signs or symptoms during this event.
Additional Manufacturer Narrative
An event of the device embolization to the main pulmonary artery and cable became detached from device during advancement was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instruction for use, "this device was sterilized with ethylene oxide and is for single use only.Do not reuse or re-sterilize this device.Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.".

• Brand Name: AMPLATZER PICCOLO
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 16807030
• Report Number: 2135147-2023-01798
• Device Sequence Number: 12288510
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/30/2023

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 Expiration Date: 07/31/2026
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 8078644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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: 18 MO
• Patient Sex: Unknown
• Patient Weight: 1 KG