MAUDE Adverse Event Report: KA MEDICAL, LLC MICRO PLUG SET; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	90002
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed and all lots of micro plug sets shipped to this account have met specification.No prior complaints related to migration have been received.
Event or Problem Description
The account alleges that during an off label micro plug implant procedure on a (b)(6) child diagnosed with patient ductus arteriosus (pda), a 5mm micro plug was first successfully deployed, migrated, and embolized within the patient's pulmonary artery.The physician then successfully externalized the device using a snare.A 6 mm micro plug device was then deployed and appeared to be stable.Approximately three hours post procedure, the micro plug migrated and embolized into the patient's pulmonary artery.The physician attempted to externalize the device from the patient using a snare unsuccessfully.The decision was made to leave the device within the patient due to the fact it was not obstructive to blood flow.The patient was then referred to surgery for successful pda ligation.The patient tolerated all procedures very well with no additional consequences to report.Patient was discharged as expected.

• Brand Name: MICRO PLUG SET
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): KA MEDICAL, LLC; 2890 centre pointe drive; roseville MN 55113
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 13290622
• Report Number: 1721504-2022-00004
• Device Sequence Number: 4547603
• Product Code: KRD
• UDI-Device Identifier: 00867966000129
• UDI-Public: 867966000129
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 90002
• 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: 01/03/2022
• Initial Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown
• Patient Weight: 3 KG