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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a sheath kink occurred.A left atrial appendage (laa) closure procedure was being performed.An anterior curve watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.After a full recapture of the device, a sheath exchange was needed since there was a kink noted in the was at the groin.The sheath was inserted through a 16fr non-boston scientific short sheath.The guidewire used to save the transseptal access and to be able to go up with a new was an 0.035 inch non-boston scientific guidewire.A pericardial effusion was noted at this time.There was a lot of movement with the guidewire to try and reposition back in the left upper pulmonary vein.The patient was stable and the case continued.A 24mm device was successfully implanted and the patient was kept on the cath lab table to watch the effusion and make sure vitals were stable.As soon as the 24mm was released, protamine was given to reverse the heparin.Activated clotting time (act) during the case was 332 seconds.After 15 minutes the effusion was measured again and it was unchanged at 1.2cm.No further intervention was required.The patient was stable but experienced symptoms of pericarditis.The patient was discharged and as of (b)(6) 2021, the patient is recovering well at home.

• 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: 11476311
• Report Number: 2134265-2021-03209
• Device Sequence Number: 3925323
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: 07/20/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025738570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/12/2021
• Patient Sequence Number: 1