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

Model Number 65-018-E4S

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

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Vi reviewed the photo and description supplied by dr.(b)(6) and believe the patient did not present with an infection but with superficial thrombophlebitis.Superficial thrombophlebitis is a known potential complication in vein procedures.The (b)(6) patient may have neglected to properly exercise and use compression.

Event Description

While performing a procedure on the left gsv using clarivein dr.(b)(6) infused 10 ml of 1% asclera (polidocanol).The patient is reported to have developed a fever (for 24 hours) and a possible "infection" 30 days after the procedure.Dr.Lin reports that any infection had mainly resolved by the time he saw the patient.He observed what he describes as a "redline" along the treatment zone.On (b)(6) 2017 dr.(b)(6), reported the patient's left leg rubor line is still present.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: 6621343
• MDR Text Key: 76953256
• Report Number: 3005831739-2017-00006
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10854339004027
• UDI-Public: (01)10854339004027(10)BM651404816I(17)190804
• 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: 06/07/2017

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 Expiration Date: 08/04/2019
• Device Model Number: 65-018-E4S
• Device Catalogue Number: 65-018-E4S
• Device Lot Number: BM651404816I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 72