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

Model Number N/A

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

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

The clarivein device was not available for investigation.There were no issues cited with device performance.No additional information or documentation was provided.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 Description

Physician verbally reported dvt post procedure where clarivein was used.

• 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: 7785544
• MDR Text Key: 117187971
• Report Number: 3005831739-2018-00037
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• 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
• Date Manufacturer Received: 07/19/2018
• 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