MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-PLUG-010
Medical Device Problem Codes	Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
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) 2023, a 10mm amplatzer vascular plug was selected for implant using a 6f non-abbott delivery system, with an inner diameter of 0.07 inches.It was noted during procedure that the plug was unable to be advanced.The decision was made to remove the plug from the patient's anatomy.It was noted after successful removal of the plug, that the plug became prematurely detached from the delivery cable.The 10mm amplatzer vascular plug had been sized selecting a plug that is 30 to 50% larger than the blood vessel diameter.The patient does not have a tortuous anatomy and the plug was not mishandled or damage at any point during device preparation.The decision was made to replace the 10mm amplatzer vascular plug with an unknown non-abbott device.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
An event of the advancement difficulty and device was completely detached from the delivery cable was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device 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.

• Brand Name: AMPLATZER VASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 16474422
• Report Number: 2135147-2023-00978
• Device Sequence Number: 12045469
• Product Code: KRD
• UDI-Device Identifier: 00811806011479
• UDI-Public: 00811806011479
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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: 9-PLUG-010
• Device Catalogue Number: 9-PLUG-010
• Device Lot Number: 8521453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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: 6F MACH1 DELIVERY SYSTEM.
• Patient Sex: Unknown