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

Model Number	10373
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a watchman access system with the related watchman delivery system (wds).The device was bloody.The tip, sheath, hub/valve were microscopically and visually inspected.Inspection revealed tip damage (misshapen/ delamination), and there were numerous kinks in the sheath.Inspection of the rest of the device found no other damage or irregularities.The reported sheath kink was confirmed.
Event or Problem Description
Reportable based on analysis completed on 22 may 2019.It was reported that a kink occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27 mm watchman laa closure device & delivery system (wds) were used.During the procedure, a kink was noted in the was as the physician was inserting the closure device into the sheath.The device then telescoped through the delivery system and the outside housing on the device crimped as well.Both the sheath and the delivery system were removed from the body.Another was inserted and the case continued and was completed without complication.There were no reported complications with the patient.However, the device analysis revealed inner liner delamination.

• Brand Name: WATCHMAN ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8705663
• Report Number: 2134265-2019-06675
• Device Sequence Number: 16662166
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0021721506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/17/2019
• Patient Sequence Number: 1
• Patient Age: 76 YR