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

Model Number 10374

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Event Description

It was reported that a device kink occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were used.The was was positioned in the laa and the wds was inserted into it.The closure device was deployed in the laa, but did not meet release criteria and needed to be fully recaptured.After this device was removed from the patient the was was noted to have kinked.The procedure was continued after this was noted and completed, there were no other complications that occurred.

• Brand Name: WATCHMAN ACCESS SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9477180
• MDR Text Key: 176631870
• Report Number: 2134265-2019-15638
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/16/2019

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: 02/20/2022
• Device Model Number: 10374
• Device Catalogue Number: 10374
• Device Lot Number: 0023383540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 80