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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a defect in the access sheath: a left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used.The closure device was being placed in the laa, but it was not seated properly so the physicians chose to recapture the device.As the device was being recaptured a defect was noted in the tip of the sheath.The was removed and exchanged for a new was.When the access sheath was looked at it was noted that the soft tip had frayed apart.There were no patient complications and a new 33mm wds and a new was were used to successfully implant and release the closure device in the laa.
Event or Problem Description
It was reported that there was a defect in the access sheath: a left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used.The closure device was being placed in the laa, but it was not seated properly so the physicians chose to recapture the device.As the device was being recaptured a defect was noted in the tip of the sheath.The was removed and exchanged for a new was.When the access sheath was looked at it was noted that the soft tip had frayed apart.There were no patient complications and a new 33mm wds and a new was were used to successfully implant and release the closure device in the laa.Device evaluated by mfr: the returned product consisted of the watchman access system (was).The device was bloody.The hub, sheath, and tip were microscopically and visually inspected.Inspection revealed tip damage (partial separation but all of tip was with the device) and numerous kinks in the sheath.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 8024272
• Report Number: 2134265-2018-62455
• Device Sequence Number: 13751736
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/29/2018

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: 06/25/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0022301195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/29/2018
• Patient Sequence Number: 1