MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE WATCHMAN® ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number M635TS20060

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(4) study.It was reported that a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was performed.A watchman access system was positioned in the laa.The hemostasis valve was unable to be tightened resulting in a leak.The procedure was completed with another watchman access system.A 24mm watchman laa closure device was implanted successfully.There were no patient complications.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6025390
• MDR Text Key: 57252436
• Report Number: 2134265-2016-09032
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/16/2016

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 Expiration Date: 10/31/2017
• Device Model Number: M635TS20060
• Device Catalogue Number: TS-2006
• Device Lot Number: 17408325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 91033431 FA
• Patient Sequence Number: 1
• Patient Age: 77 YR