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

Model Number	TU-8001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombus occurred.A left atrial appendage (laa) closure procedure was being performed using transesophageal echocardiogram (tee) imaging.Venous access was obtained and transseptal puncture (tsp) was performed through a thick septum using a single curve watchman access sheath (was).A pigtail catheter was inserted into the laa.Heparin had been administered.A 20mm watchman flx closure device and delivery system (wd) was advanced and positioned at the laa then subsequently deployed.A thrombus was noted to have formed and attached to the was.It was noted the activated clotting time (act) was high out of range over 400.Release criteria was met and the watchman flx closure device was released and implanted.The physician decided to remove the was and no patient adverse effects were noted.The procedure was concluded.
Additional Manufacturer Narrative
B5: information added.
Event or Problem Description
It was reported that thrombus occurred.A left atrial appendage (laa) closure procedure was being performed using transesophageal echocardiogram (tee) imaging.Venous access was obtained and transseptal puncture (tsp) was performed through a thick septum using a single curve watchman access sheath (was).A pigtail catheter was inserted into the laa.Heparin had been administered.A 20mm watchman flx closure device and delivery system (wd) was advanced and positioned at the laa then subsequently deployed.A thrombus was noted to have formed and attached to the was.It was noted the activated clotting time (act) was high out of range over 400.Release criteria was met and the watchman flx closure device was released and implanted.The physician decided to remove the was and no patient adverse effects were noted.The procedure was concluded.It was further reported the patient was discharged home in a routine fashion post procedure.

• Brand Name: WATCHMAN FXD CURVE ACCESS SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19756725
• Report Number: 2124215-2024-40825
• Device Sequence Number: 6491617
• Product Code: DQY
• UDI-Device Identifier: 00191506013806
• UDI-Public: 00191506013806
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: 01/26/2026
• Device Model Number: TU-8001
• Device Catalogue Number: TU-8001
• Device Lot Number: 0030933554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/26/2024
• Date Device Manufactured: 01/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female