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

Model Number	10373
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device damage occurred.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.While the wds was placed into the was, a kink to the sheath was noted.The physician was able to manage the sheath in such a way to obtain minimal resistance and proceed with deployment.After the device was successfully deployed, a 1cm strand of what appeared to be a potential thrombus or fibrous tissue was noted on the tip of the was.At this time, the physician aspirated the sheath in attempt to resolve the object, but no change occurred via transesophageal echocardiogram (tee).The device was released and implanted.The sheath was then pulled out of the patient at which point the physician noted a thin wire protruding from the tip of the sheath.The physician attempted to remove the wire, but was not able to separate it from the sheath.No further damage was noted to the sheath.No patient complications occurred.
Additional Manufacturer Narrative
Product investigation completed.Returned product consisted of watchman access system with part of the sheath and hub/valve missing (not returned).The customer supplied a photo of the reported wire protruding from the tip.Analysis of the supplied photo, tip, and sheath included microscopic and visual inspection.Inspection revealed tip damage (delamination of the inner liner/stretched/misshapen), and kinks in the sheath located 8cm and 19cm from the tip of the device.The photo showed a filament protruding out from the inside of the tip, and was consistent with delamination of the ptfe liner, and is consistent with the observed delamination on the returned device.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that device damage occurred.A watchman access system (was) was positioned and a watchman laa closure device & delivery system (wds) were selected for use during a left atrial appendage (laa) closure procedure.While the wds was placed into the was, a kink to the sheath was noted.The physician was able to manage the sheath in such a way to obtain minimal resistance and proceed with deployment.After the device was successfully deployed, a 1cm strand of what appeared to be a potential thrombus or fibrous tissue was noted on the tip of the was.At this time, the physician aspirated the sheath in attempt to resolve the object, but no change occurred via transesophageal echocardiogram (tee).The device was released and implanted.The sheath was then pulled out of the patient at which point the physician noted a thin wire protruding from the tip of the sheath.The physician attempted to remove the wire, but was not able to separate it from the sheath.No further damage was noted to the sheath.No patient complications occurred.

• 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: 9547193
• Report Number: 2134265-2019-16332
• Device Sequence Number: 2408233
• Product Code: NGV
• UDI-Device Identifier: 08714729838197
• UDI-Public: 08714729838197
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/05/2020

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: 12/12/2021
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0023077814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1