MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	7805
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a thrombus present.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) and a 24mm watchman flx pro laa closure device & delivery system (wds) were selected to be used.10,00 units of heparin was given prior to the transeptal puncture.The transseptal puncture was then completed and the physician positioned the was in the laa of the patient.A second dose of 10,000 units of heparin was given after the transseptal puncture.The wds was prepared, and the expo pigtail catheter was removed but came out with a thrombus present.The physician removed the was and all products from the patient.An additional 10,000 units of heparin was given to the patient, and the procedure was continued with all new products.The procedure was completed with the closure device implanted in the laa of the patient.The patient did not experience any complications as a result of this event.The patient will be observed for six (6) hours post procedure and then be discharged home.

• Brand Name: EXPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21242082
• Report Number: 2124215-2025-03305
• Device Sequence Number: 3642311
• Product Code: DQO
• UDI-Device Identifier: 08714729366713
• UDI-Public: 08714729366713
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• 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
• Report Date (Section B): 01/27/2025

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 Model Number: 7805
• Device Catalogue Number: 7805
• 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: 01/08/2025
• Initial Report FDA Received Date: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female