MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 12-80-10

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected part was returned to livanova (b)(4) for a detailed investigation.The investigator could reproduce the reported issue.The problem could be traced to faulty mechanical tolerances at the bearing seat of the linear actuator.The parts will be replaced to solve the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a electrical venous occluder (evo) was giving an error code associated to the encoder during procedure.There was no report of patient injury.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 10725947
• MDR Text Key: 212721183
• Report Number: 9611109-2020-00592
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12-80-10
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1