MAUDE Adverse Event Report: VASCULAR INSIGHTS LLC CLARIVEIN IC INFUSION CATHETER

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem Thrombus (2101)

Event Date 06/24/2017

Event Type  Injury  

Manufacturer Narrative

The clarivein device was not available for investigation.There were no issues cited with device performance.Potential adverse effects that might be associated with the clarivein® device are similar to those associated with any interventional vascular procedure.The ifu provided with the clarivein device lists the potential adverse events that might be encountered during a peripheral vasculature infusion procedure using the clarivein® ic as well as instructs the user to consult labeling of agents to be delivered prior to infusion.

Event Description

Clarivein® device was used to deliver 2% polidocanol to right ssv and bilateral gsv.Post procedure a small clot in the right distal gastrocnemius vein was observed post procedure.The device did not malfunction.

• Brand Name: CLARIVEIN IC INFUSION CATHETER
• Type of Device: CLARIVEIN IC INFUSION CATHETER
• Manufacturer (Section D): VASCULAR INSIGHTS LLC; 1 pinehill dr.; two batterymarch park; quincy MA 02169
• Manufacturer (Section G): CONTRACT MANUFACTURED FOR VASCULAR INSIGHTS LLC; 1 pinehill dr.; two batterymarch pk suite 100; quincy MA 02169
• Manufacturer Contact: paul piselli ; 1 pinehill dr.; two batterymarch pk. suite 100; quincy, MA 02169 ; 2034465711
• MDR Report Key: 6767111
• MDR Text Key: 81819507
• Report Number: 3005831739-2017-00011
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR