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

Model Number	10373
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was resistance felt and damage to the access system.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The was was positioned in the laa and the closure device was inserted into the was.Upon deployment of the device, the physician noted additional resistance was felt.The device was still able to be successfully deployed and implanted in the laa of the patient.Upon removal of the was from the body, the physician noticed that at the distal end there was an exposed thread or filament or a piece of the inner lining of the sheath that was exposed.They believed that this was causing the resistance and complicating the procedure.Ultimately, the procedure was successful and no complications to the patient were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned device consisted of a watchman access system with a wds snapped inside the device.The devices were separated for lab analysis.The tip and sheath were microscopically and visually inspected.Inspection revealed tip damage (delamination/liner pulled) and part of the liner pulled through the tip.Inspection of the rest of the device found no other damage or irregularities.The was was functionally tested (for resistance) with the related wds.The wds was loaded into the hemostasis valve if the was and advanced through the sheath until it exited out of the tip.There was no resistance or friction felt.
Event or Problem Description
It was reported that there was resistance felt and damage to the access system.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The was was positioned in the laa and the closure device was inserted into the was.Upon deployment of the device, the physician noted additional resistance was felt.The device was still able to be successfully deployed and implanted in the laa of the patient.Upon removal of the was from the body, the physician noticed that at the distal end there was an exposed thread or filament or a piece of the inner lining of the sheath that was exposed.They believed that this was causing the resistance and complicating the procedure.Ultimately, the procedure was successful and no complications to the patient were reported.

• 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: 8753174
• Report Number: 2134265-2019-07633
• Device Sequence Number: 11179593
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 08/01/2019

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: 11/13/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0022936015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/01/2019
• Patient Sequence Number: 1