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 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device evaluated by mfr.The complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system was prepared and flushed successfully.The transseptal puncture was performed and the guide wire was in position.The access system was inserted and the dilator and guide wire were removed.However, the hemostasis valve on the access system was unable to close and blood was leaking out of it.They attempted to unscrew and close the valve three times, but were unsuccessful.They exchanged the access system for a new one which was used to successfully complete the procedure.There were no patient complications and the patient's condition is stable.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6309185
• MDR Text Key: 66774216
• Report Number: 2134265-2017-00596
• 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
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: M635TS20060
• Device Catalogue Number: TS-2006
• Device Lot Number: 0019483429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 90