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

Model Number	M635TU70040
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a kink occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman truseal double curve access system (was) was initially attempted, but exchanged for a watchman truseal anterior curve access system to optimize a coaxial approach into the anterior lobe of the laa.While attempting to position a 27mm watchman flx laa closure device with delivery system(wds) with the was, it was noticed on fluoroscopy that there was a kink in the distal aspect of the was.The implanter decided to continue with one more attempt at an implant as the device was thought to be still in an acceptable position despite the kink.The closure device was then fully recaptured with the was after assessment showed the position to be unfavorable in the laa.There were no issues when recapturing.The was was then completely removed from the patient allowing for a new transseptal puncture in order to try and optimize the coaxial approach into the laa with a double curve was.The procedure was completed successfully.

• 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: 11912900
• Report Number: 2134265-2021-07061
• Device Sequence Number: 17200152
• Product Code: DQY
• UDI-Device Identifier: 08714729965725
• UDI-Public: 08714729965725
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/01/2021

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: 05/20/2022
• Device Model Number: M635TU70040
• Device Catalogue Number: M635TU70040
• Device Lot Number: 0023825307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/01/2021
• Patient Sequence Number: 1