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

Model Number	10373
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the access system sheath kinked.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used.Multiple recaptures of the 30mm device was performed.They switched out the was sheath to ensure it was not kinked.Upon removal, it was noted to be deformed.A second was used and finished the case.
Event or Problem Description
It was reported that the access system sheath kinked.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used.Multiple recaptures of the 30mm device was performed.They switched out the was sheath to ensure it was not kinked.Upon removal, it was noted to be deformed.A second was was used and finished the case.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned device consisted of a watchman truseal access system device.The device was bloody.Analysis of the tip and sheath included microscopic and visual inspection.Inspection revealed tip damage (flattened), and sheath kinks located 27.5cm, 38cm, 75.5cm from the tip of the device.Inspection of the rest of the device found no other damage or defect.The reported tip damage was confirmed.

• 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: 10929426
• Report Number: 2134265-2020-16742
• Device Sequence Number: 3034197
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 01/25/2021

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: 02/24/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025258694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/25/2021
• Patient Sequence Number: 1
• Patient Age: 60 YR