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

Model Number	M635TU70010
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed on a patient with a severely rotated heart.A double curve watchman truseal access system (was) was positioned and a 24mm watchman laa closure device & delivery system (wds) were used.After going transseptal and getting the double curve was sheath and pigtail into the appendage they were able to see that the appendage was heading in a direction that was opposite of transesophageal echo (tee).They attempted to deploy a 24mm device, but were unsuccessful.They decided that they would need to cross the septum in a different spot in order to have a chance at closing the anatomy.The images were difficult to obtain as they were unable to see the sheath.They crossed the septum again and got the guidewire into the upper pulmonary vein.When attempting to get the second single curve truseal was across the septum the torque pulled the guidewire out and back into the right atrium.A sweep was performed after both the first and second attempts and no effusion was noted.A third attempt was done more superior/anterior and they were able to cross.At this point they were across and advancing the single curve truseal was up when they noticed a drop in blood pressure.A pericardial effusion was noted anterior on echo and the patient was prepped for a pericardiocentesis.Approximately 200-250cc of fluid were pulled off and the drain was left in place.The case was aborted.The patient was reported to be doing fine.

• Brand Name: WATCHMAN TRUSEAL 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: 11328059
• Report Number: 2134265-2021-01636
• Device Sequence Number: 19111282
• Product Code: DQY
• UDI-Device Identifier: 08714729965701
• UDI-Public: 08714729965701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: M635TU70010
• Device Catalogue Number: M635TU70010
• Device Lot Number: 0026347740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention