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

Model Number 12-80-10

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

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 livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported event.He sent the affected device to the manufacturer site for a detailed investigation and repair.Investigation results confirmed the reported issue.The root cause has been identified as a decreased strength of the clamp motor due to aging effects.To compensate these effects the motor current was slightly increased within the specifications.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 an electrical venous occluder (evo) was not closing properly 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: 9127451
• MDR Text Key: 194176724
• Report Number: 9611109-2019-00752
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/26/2019

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
• Device Operator: Health Professional
• Device Model Number: 12-80-10
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2010
• 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