MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. FOUNTAIN.INFUSION CATHETER.

Model Number	00884450025482
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a slow-continuous vascular infusion procedure, the occlusion wire placed within the catheter to activate the uniform dispersion of therapeutic agents within the patient detached within the vascular system.The physician successfully retrieved the foreign body from the patient with a vascular snare device.No additional patient consequences to report.

• Brand Name: FOUNTAIN.INFUSION CATHETER.
• Common Device Name: INFUSION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10587510
• Report Number: 1721504-2020-00075
• Device Sequence Number: 1218941
• Product Code: KRA
• UDI-Device Identifier: 00884450025482
• UDI-Public: 00884450025482
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K974067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 09/20/2022
• Device Model Number: 00884450025482
• Device Catalogue Number: FIS4-90-40
• Device Lot Number: H1675894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFUSION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention