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

Model Number TU-8002

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

It was reported that difficulty recapturing occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd double curve access system (was) was inserted and positioned at the laa, although poor trajectory (mid and inferior) was noted.A 40mm watchman flx pro closure device and delivery system (wds) was advanced, deployed, fully recaptured with difficulty and removed.A pigtail guidewire was inserted.A second 40mm wds was advanced, deployed, did not meet release criteria so it was subsequently fully recaptured and removed.A 35mm wds was advanced, deployed, and did not meet release criteria so it was subsequently fully recaptured with difficulty and removed.The physicians decided to abort the procedure due to the patient's anatomy.It was noted that due to the challenging anatomy, several recaptures were performed with the wdss.It was also noted that the fabric cap of the wds seemed to be getting stuck on the tip of the was, and a kink was observed on the was proximal to the proximal marker band before the curve of the sheath.The patient was discharged the same day without patient complications.

• Brand Name: WATCHMAN FXD CURVE ACCESS SYSTEM
• Type of Device: 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: 18923537
• MDR Text Key: 337897533
• Report Number: 2124215-2024-15587
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00191506013813
• UDI-Public: 00191506013813
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TU-8002
• Device Catalogue Number: TU-8002
• Device Lot Number: 0032984894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male