MAUDE Adverse Event Report: ESTECH, INC. LIV; SUTURE Catcher, CARDIOVASCULAR

Catalog Number 340-7475

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

Incorrect instrument count- minimal invasive catcher instrument tip broke off.Doctor stated the tip went on the floor and it was micro in size.The field and floor were searched but unable to locate tip.Doctor stated no x-ray in operating room and asked to order chest x-ray post-op for rule out of foreign body.

Event Description

Incorrect instrument count- minimal invasive catcher instrument tip broke off.Doctor stated the tip went on the floor and it was micro in size.The field and floor were searched but unable to locate tip.Doctor stated no x-ray in or and asked to order chest x-ray post-op for rule out of foreign body.

Event Description

Incorrect instrument count- minimal invasive catcher instrument tip broke off.Doctor stated the tip went on the floor and it was micro in size.The field and floor were searched but unable to locate tip.Doctor stated no x-ray in or and asked to order chest x-ray post-op for rule out of foreign body.

• Brand Name: LIV
• Type of Device: SUTURE Catcher, CARDIOVASCULAR
• Manufacturer (Section D): ESTECH, INC.; 2603 camino ramon; san ramon CA 94583
• MDR Report Key: 5438547
• MDR Text Key: 38253289
• Report Number: 5438547
• Device Sequence Number: 0
• Product Code: DWS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 340-7475
• Device Lot Number: 001-340-7475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2016; 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1