MAUDE Adverse Event Report: KA MEDICAL MICRO PLUG SET; NON-NEUROVASCULAR EMBOLIZATION PLUG, METALLIC

Catalog Number	KA90002
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that while using a 5 mm micro plug set to close a pda in a 2 kg baby via femoral venous approach, the device prematurely disconnected during deployment from the distal end of the delivery catheter and embolized into the descending aorta.An introducer sheath was placed in the femoral artery and the device was retrieved with a snare.A new 5 mm micro plug set was used to close the pda.No patient injury.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

• Brand Name: MICRO PLUG SET
• Common Device Name: NON-NEUROVASCULAR EMBOLIZATION PLUG, METALLIC
• Manufacturer (Section D): KA MEDICAL; 1265 grey fox road; suite 550; arden hills MN 55112
• Manufacturer (Section G): KA MEDICAL; 1265 grey fox road; suite 550; arden hills MN 55112
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25126299
• Report Number: 3012276280-2026-00100
• Device Sequence Number: 8634637
• Product Code: KRD
• UDI-Device Identifier: 00867966000129
• UDI-Public: 00867966000129
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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
• Device Catalogue Number: KA90002
• Device Lot Number: 204674F817280201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 2 KG