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	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sheath kink occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.Upon assessing the laa with the was, a kink occurred on the distal end.The decision was made to continue using that was and not exchange it.The wds was advanced into the was and the closure device was deployed.Immediately following device deployment, the device perforated the laa leading to a pericardial effusion.There was no initial hemodynamic compromise noted from the perforation.The device was left in place and implanted to avoid causing a tear or hole in the laa and to allow the pericardial effusion to be controlled.Protamine was given and a pericardiocentesis was attempted.A pneumothorax occurred due to the attempted and failed pericardiocentesis and a chest tube was inserted.The patient remains hospitalized in stable condition with the chest tube in place.The patient is expected to make a full recovery.
Event or Problem Description
It was reported that a sheath kink occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.Upon assessing the laa with the was, a kink occurred on the distal end.The decision was made to continue using that was and not exchange it.The wds was advanced into the was and the closure device was deployed.Immediately following device deployment, the device perforated the laa leading to a pericardial effusion.There was no initial hemodynamic compromise noted from the perforation.The device was left in place and implanted to avoid causing a tear or hole in the laa and to allow the pericardial effusion to be controlled.Protamine was given and a pericardiocentesis was attempted.A pneumothorax occurred due to the attempted and failed pericardiocentesis and a chest tube was inserted.The patient remains hospitalized in stable condition with the chest tube in place.The patient is expected to make a full recovery.
Additional Manufacturer Narrative
Correction: h6 evaluation conclusion code - updated from no problem detected to adverse event related to procedure.

• 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: 11887240
• Report Number: 2134265-2021-06781
• Device Sequence Number: 3399858
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 08/13/2021

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: 07/17/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025734465
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Patient Age: 79 YR