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

Catalog Number 90003

Device Problem Off-Label Use (1494)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2021

Event Type  Injury  

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 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
• Type of Device: 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: 13290627
• MDR Text Key: 284027622
• Report Number: 1721504-2022-00005
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00867966000136
• UDI-Public: 867966000136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 3 KG