MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CLARIVEIN OC INFUSION CATHETER

Model Number	65-018-E4S
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a mechanochemical ablation (moca) procedure, the distal rotating catheter became stuck with a valve of a targeted vasculature.The physician had acquired antegrade venous access through a vascular sheath and was attempting to deliver sclerosant through the rotating catheter when the catheter became entangled within a valve of the periphery.All attempts by the physician to dislodge the rotating catheter were unsuccessful.A surgical "cutdown" procedure was necessary to safely and successfully dislodge the rotating catheter form the patient's periphery with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.A root cause could not be determined.A search of the complaint database was performed and one similar complaint for this lot number from the same customer was found.The device history record was reviewed and no exception documents were found.

• Brand Name: CLARIVEIN OC INFUSION CATHETER
• Common Device Name: INFUSION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 9857526
• Report Number: 1721504-2020-00015
• Device Sequence Number: 19659938
• Product Code: KRA
• UDI-Device Identifier: 10854339004027
• UDI-Public: 10854339004027
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K071468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: 65-018-E4S
• Device Catalogue Number: O-65-018-E4S
• Device Lot Number: BM651404118O
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention