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

Model Number 65-018-E4S

Device Problem Fitting Problem (2183)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

This failure mode was fully investigated and was isolated to one lot of product as identified in this report.Root cause analysis was performed and corrective actions identified and implemented.Since the implementation of corrective action there have been no further events of this nature reported.

Event Description

Physician removed the clarivein catheter part number (b)(4) from the packaging and observed the dispersion wire unsheathed out of the catheter sheath.Physician discarded the device and opened a new one to complete the procedure with no other issues.

• 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: 7321058
• MDR Text Key: 101965796
• Report Number: 3005831739-2018-00025
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10854339004027
• UDI-Public: (01)10854339004027(10)BM651403017I(17)200724
• 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: Recall
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2020
• Device Model Number: 65-018-E4S
• Device Catalogue Number: N/A
• Device Lot Number: BM651403017I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3005831739-11-09-17-123R
• Patient Sequence Number: 1