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	09/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device kinked.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 inserted and properly positioned in the laa of the patient.The physician deployed a closure device but release criteria was not met.Upon attempting to fully recapture, the was was kinked and the closure device was unable to be pulled into the sheath.Eventually, the physician was able to fully recapture the device into the kinked sheath and removed it from the body.The patient remained stable and no effusion developed.The procedure was aborted and the patient was discharged.
Event or Problem Description
It was reported that a device kinked.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 inserted and properly positioned in the laa of the patient.The physician deployed a closure device but release criteria was not met.Upon attempting to fully recapture, the was was kinked and the closure device was unable to be pulled into the sheath.Eventually, the physician was able to fully recapture the device into the kinked sheath and removed it from the body.The patient remained stable and no effusion developed.The procedure was aborted and the patient was discharged.
Additional Manufacturer Narrative
The returned product consisted of a watchman access system with the dilator in the sheath and the related event device the device was bloody.Analysis of the tip, sheath, and hub/valve included microscopic and visual inspection.Inspection revealed numerous kinks in the sheath and damage to the tip (inverted/misshapen/stretched).Inspection of the rest of the device found no other damage or defects.

• 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: 10588831
• Report Number: 2134265-2020-13225
• Device Sequence Number: 16838930
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/21/2020

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: 01/30/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025136060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1