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

Model Number O-65-018-E4S

Device Problems Entrapment of Device (1212); Device Inoperable (1663)

Patient Problem Tissue Damage (2104)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

The clarivein oc product is not marketed in the usa.

Event Description

During a procedure in which the clarivein oc infusion catheter was used, physician reported that while navigating the catheter through the vasculature, the dispersion wire became caught on the vessel tissue.While attempting to remove the catheter, the dispersion wire was found to be broken, resulting in a 16 cm wire fragment, which the physician removed using a clamp via a 5cm incision under local anesthetic.The physician noted that the catheter assembly portion of the clarivein device did not lock into the mdu portion of the device (motor drive unit).

• Brand Name: CLARIVEIN OC INFUSION CATHETER
• Type of Device: CLARIVEIN OC 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: 7150569
• MDR Text Key: 96122598
• Report Number: 3005831739-2017-00016
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2020
• Device Model Number: O-65-018-E4S
• Device Lot Number: SP65E140454535O
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR