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

Model Number	10373
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported air was in the sheath and the procedure was cancelled.A left atrial appendage (laa) closure procedure was being performed.The patient had a thrombus on the transseptal guidewire and sheath, so both were removed and pressure was held on the right femoral vein.A small hematoma was noted so pressure was held.The left femoral vein was used, and the transseptal was successful.A double curve watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.The 27mm device was under compressed, so a 30mm device was prepped.The was sheath was getting air in the sheath and would not bleed back so a new double curve was was placed.The 30mm device was inserted and it was noticed the patient had a drop in blood pressure and the sheath was still was not bleeding back.A large hematoma was found in the right groin.The 30 mm device was removed, and the sheath was brought to the right side and protamine was given.Pressure was held to the groin, and 2 units of blood were given.The patient was stable two hours post-procedure.The physician felt that the air was caused by loss of volume creating a low pressure system in the left atrium.The patient was discharged (b)(6) 2021.
Event or Problem Description
It was reported air was in the sheath and the procedure was cancelled.A left atrial appendage (laa) closure procedure was being performed.The patient had a thrombus on the transseptal guidewire and sheath, so both were removed and pressure was held on the right femoral vein.A small hematoma was noted so pressure was held.The left femoral vein was used, and the transseptal was successful.A double curve watchman access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used.The 27mm device was under compressed, so a 30mm device was prepped.The was sheath was getting air in the sheath and would not bleed back so a new double curve was was placed.The 30mm device was inserted and it was noticed the patient had a drop in blood pressure and the sheath was still was not bleeding back.A large hematoma was found in the right groin.The 30 mm device was removed, and the sheath was brought to the right side and protamine was given.Pressure was held to the groin, and 2 units of blood were given.The patient was stable two hours post-procedure.The physician felt that the air was caused by loss of volume creating a low pressure system in the left atrium.The patient was discharged (b)(6) 2021.It was further reported that the patient's blood pressure dropped to 70 systolic during the procedure.The estimated blood loss from the procedure was 500-600cc and the blood loss was femoral only.

• 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: 11233441
• Report Number: 2134265-2021-00709
• Device Sequence Number: 3286013
• Product Code: NGV
• UDI-Device Identifier: 08714729838203
• UDI-Public: 08714729838203
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/04/2021

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: 03/02/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025288040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 66