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

Model Number	VSICE2D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Blocks b6 & b7: 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 discarded, thus no returned product investigation was performed.Block h6: per the ifu, perforation is listed as a known risk of complication 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 therapeutic electrophysiology procedure.During insertion, resistance was encountered, but was able to advance to the left femoral vein.However, after the procedure, the patient experienced a retroperitoneal bleed, and a closure device was used to stop the bleeding.At this point, the procedure was completed and the patient is doing well.This adverse event is being submitted because the verisight was in use when a perforation occurred, requiring intervention.

• Brand Name: VERISIGHT 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: 22845802
• Report Number: 3008363989-2025-00103
• Device Sequence Number: 13170528
• Product Code: OBJ
• UDI-Device Identifier: 00845225003029
• UDI-Public: (01)00845225003029(11)250305(17)260305(10)0303422431
• 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): 08/19/2025

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: 03/05/2026
• Device Model Number: VSICE2D
• Device Catalogue Number: VSICE2D
• Device Lot Number: 0303422431
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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: INTRODUCER SHEATH, MFG AND SIZE UNK; PHILIPS: EPIQ SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown