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

Model Number M635TU20060

Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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

It was reported a hemostasis valve leak occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman® access system was used.When the access system crossed to the left side, the wire was removed and the hemostasis valve could not be tightened completely; it came unthreaded.They attempted to open the valve completely and re-close it, but that did not solve the problem.The hemostasis valve was leaking a minimal amount of blood, but there were no complications to the patient.They removed the access system from the patient and inserted an amplatz wire to exchange for a new access system.The procedure was successfully completed with the new access system.

• Brand Name: WATCHMAN® ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6670085
• MDR Text Key: 78482375
• Report Number: 2134265-2017-06655
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: (01)08714729838203(17)20200322(10)0020440756
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2020
• Device Model Number: M635TU20060
• Device Catalogue Number: TU2006
• Device Lot Number: 0020440756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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