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

Model Number	65-018-E4S
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Vascular System (Circulation), Impaired (2572)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This failure mode, difficulty of insertion, 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 or Problem Description
The doctor prepared the patient for the procedure by inserting the introducer sheath.Physician removed the clarivein catheter part number (b)(4) from the packaging and proceeded to insert the catheter assembly into the introducer sheath.The physician encountered difficulty advancing the catheter into the introducer sheath.Physician discarded the device and opened a new one to complete the procedure with no other issues.

• Brand Name: CLARIVEIN IC INFUSION CATHETER
• Common Device Name: CLARIVEIN IC INFUSION CATHETER
• Manufacturer (Section D): VASCULAR INSIGHTS LLC; 1 pinehill dr.; two batterymarch park; quincy MA 02169
• MDR Report Key: 7317429
• Report Number: 3005831739-2018-00006
• Device Sequence Number: 16180810
• Product Code: KRA
• UDI-Device Identifier: 10854339004027
• UDI-Public: (01)10854339004027(10)BM651403017I(17)200724
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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
• Operator of Device: 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005831739-11-09-17-123R
• Patient Sequence Number: 1