MAUDE Adverse Event Report: VOLCANO CORPORATION VERISIGHT PRO INTRACARDIAC ECHOCARIOGRAPHY CATHETER; CATHETER, IMAGAING, ULTRASOUND

Model Number	VSICE3D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a3b & a4: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the verisight catheter was not returned, thus no product investigation was performed.Block h6: per the ifu, cardiac tamponade is listed as a possible adverse effect with use of the verisight catheter.Blocks h7, h9 & h10: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s).
Event or Problem Description
It was reported that a verisight catheter was used in a venous structural heart procedure.During use, the catheter was positioned in the left atrium, when the patient developed a pericardial effusion which led to a cardiac tamponade.The catheter was recaptured and removed along with the watchman sheath.Then, a pericardiocentesis was performed, patient was intubated, followed by surgical intervention (thoracotomy and laa ligation/repair).The procedure was completed and patient is in good condition.This adverse event is being submitted because the verisight was in use when the patient experienced a cardiac tamponade, requiring intervention.There was no alleged malfunction with the verisight catheter.

• Brand Name: VERISIGHT PRO INTRACARDIAC ECHOCARIOGRAPHY CATHETER
• Common Device Name: CATHETER, IMAGAING, ULTRASOUND
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 23067763
• Report Number: 3008363989-2025-00109
• Device Sequence Number: 13181925
• Product Code: OBJ
• UDI-Device Identifier: 00845225003036
• UDI-Public: (01)00845225003036(11)250423(17)260423(10)0303445610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 Expiration Date: 04/23/2026
• Device Model Number: VSICE3D
• Device Catalogue Number: VSICE3D
• Device Lot Number: 0303445610
• 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: 08/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC: 15F WATCHMAN INTRODUCER SHEATH; PHILIPS: EPIQ SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White