MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Catalog Number M635TU20060

Device Problems Torn Material (3024); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Event Description

The patient came in for a watchman procedure.While performing a tug test for device, the device did not stay in place.When removed from the body it was noted that a piece of the delivery system tore away and remained on the tines if the watchman device.No harm to the patient occurred.Continued the procedure with a new delivery system and device.

• Brand Name: WATCHMAN
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 5905 nathan lane; plymouth MN 55442
• MDR Report Key: 6452839
• MDR Text Key: 71489038
• Report Number: 6452839
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• 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
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: M635TU20060
• Device Lot Number: 18452577
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.; UNKNOWN.
• Patient Age: 71 YR