MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. FOUNTAIN INFUSION CATHETER; PERIPHERAL/CORONARY VASCULAR INFUSION CATHETER

Model Number	00884450023457
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges while placing an infusion catheter within the femoral vein of a patient diagnosed with deep venous thrombosis [dvt] the catheter kinked and detached within the femoral vein.The clinician performed a cutdown procedure to successfully remove the foreign body from the patient.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Only part of the suspect device was returned for investigation.The partial device was examined visually, and microscopically and functional testing was performed.The complaint is confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the complete device be returned at a later time, the investigation will be reopened.

• Brand Name: FOUNTAIN INFUSION CATHETER
• Common Device Name: PERIPHERAL/CORONARY VASCULAR INFUSION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 14861638
• Report Number: 1721504-2022-00057
• Device Sequence Number: 4807911
• Product Code: KRA
• UDI-Device Identifier: 00884450023457
• UDI-Public: 00884450023457
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: 00884450023457
• Device Catalogue Number: FIS4-45-20
• Device Lot Number: H2122328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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