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

Catalog Number 65-018-E4S

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

Patient Problem Thrombosis (2100)

Event Date 02/19/2019

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 during a post mechanochemical ablation (moca) procedure the patient acquired deep vein thrombosis [dvt].The ablation catheter was used to deliver approximately 10cc of 2% asclera into the patient's great saphenous vein [gsv].Approximately 60cm of the gsv had been successfully treated during the procedure.During a follow up visit on (b)(6) 2019, the physician states that the patient's dvt may or may not have been related to the patient's original gsv ablation procedure that completed on (b)(6) 2019.Due to the development of dvt, the follow up ablation procedure was cancelled, and the patient was started on anticoagulants.

• Brand Name: CLARIVEIN IC INFUSION CATHETER
• Type of Device: INFUSION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8425053
• MDR Text Key: 138938908
• Report Number: 1721504-2019-00024
• Device Sequence Number: 1
• Product Code: KRA
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 65-018-E4S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/15/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 70 YR