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

Model Number 65-018-E4S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that on (b)(6) 2020 a mechanical occlusion chemical ablation [moca] procedure was successfully completed on a patient.The patient was discharged to home later that day.On (b)(6) 2020 the practice was notified by a family member that the patient had been admitted to the hospital and diagnosed with a pulmonary embolism [pe].

• Brand Name: CLARIVEIN IC INFUSION CATHETER
• Type of Device: INFUSION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, ut
• MDR Report Key: 9989050
• MDR Text Key: 188864533
• Report Number: 1721504-2020-00026
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10854339004027
• UDI-Public: 10854339004027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 65-018-E4S
• Device Catalogue Number: 65-018-E4S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization; Life Threatening; Required Intervention