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	Perforation of Vessels (2135)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a verisight pro catheter was used in an inferior vena cava filter (ivcf) procedure.Prior to use of the catheter, a non-philips introducer sheath was inserted into the ivc.While advancing the catheter in the introducer sheath, an ivc perforation was noted.It was suspected that the introducer sheath did some initial damage to the ivc; however, no symptoms were noted after sheath advancement.The ivc was repaired with aaa endoprosthesis, and the procedure was completed successfully.This adverse event is being submitted because the verisight was in use when a perforation occurred, requiring intervention.There was no alleged malfunction with the verisight.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a3b: date of birth and gender not available from facility.Block 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 not returned, thus no 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).

• 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 23832425
• Report Number: 3008363989-2025-00165
• Device Sequence Number: 21090144
• Product Code: OBJ
• UDI-Device Identifier: 00845225003036
• UDI-Public: (01)00845225003036(11)250901(17)260901(10)0303566049
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: 09/01/2026
• Device Model Number: VSICE3D
• Device Catalogue Number: VSICE3D
• Device Lot Number: 0303566049
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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: GORE: 10F, DRYSEAL INTRODUCER SHEATH; PHILIPS: EPIQ SYSTEM
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White