MAUDE Adverse Event Report: VASCULAR INSIGHTS LLC CLARIVEIN; CONTINUOUS FLUSH CATHETER

Model Number 65-018-E4S

Device Problem Insufficient Information (3190)

Patient Problems Syncope (1610); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

The device performed as designed with no malfunction.The clarivein instructions for use state "do not use the clarivein ic in patients contraindicated for endovascular procedures".Device not made available by physician.

Event Description

Physician used the clarivein catheter to infuse physician specified medication to the peripheral vascular.Physician successfully closed a left great saphenous vein (gsv) on (b)(6) 2015 followed by a right, small saphenous vein (ssv) on (b)(6) 2015.It is reported that the (b)(6)-year-old male patient tolerated the procedures well and no complications or adverse events were noted immediately after the procedures.It was reported the patient had an accident (syncope episode) shortly after the right ssv ablation and was admitted to the hospital.Ultrasound examination showed acute dvt bilaterally.Note: physician injected 2% polidocanol.

• Brand Name: CLARIVEIN
• Type of Device: CONTINUOUS FLUSH CATHETER
• Manufacturer (Section D): VASCULAR INSIGHTS LLC; 1 pinehill dr.; two batterymarch park; quincy MA 02169
• Manufacturer (Section G): VASCULAR INSIGHTS LLC; 1 pinehill dr.; two batterymarch park; quincy MA 02169
• Manufacturer Contact: paul piselli ; 1 pinehill dr.; two batterymarch park; quincy, MA 02169 ; 2034465711
• MDR Report Key: 5386157
• MDR Text Key: 36672230
• Report Number: 3005831739-2015-00005
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 071468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 65-018-E4S
• Device Catalogue Number: 65-018-E4S
• Device Lot Number: BM651402315I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• 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
• Patient Age: 66 YR