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

Model Number	85-018-E140S
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clarivein device was not available for investigation.There were no issues cited with device performance.The investigation results were inconclusive but out of an abundance of caution vascular insights has decided to file an mdr within the specified 30 day reporting period.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 or Problem Description
Physician reported a deep vein thrombosis (dvt) post procedure where clarivein was used to deliver sclerosants.

• Brand Name: CLARIVEIN IC INFUSION CATHETER
• Common Device Name: CLARIVEIN IC INFUSION CATHETER
• Manufacturer (Section D): VASCULAR INSIGHTS LLC; 1 pinehill dr.; two batterymarch park; quincy MA 02169
• MDR Report Key: 7610782
• Report Number: 3005831739-2018-00034
• Device Sequence Number: 134528
• Product Code: KRA
• UDI-Device Identifier: 10854339004034
• UDI-Public: (01)10854339004034(10)BM85E140S2716I(17)190707
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2019
• Device Model Number: 85-018-E140S
• Device Catalogue Number: N/A
• Device Lot Number: BM85E140S2716I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention