MAUDE Adverse Event Report: VOLCANO CORPORATION VERISIGHT PRO INTRACARDIAC ECHOCARDIOGRAPHY 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 Perforation (2513)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Blocks a2-a6: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.The verisight catheter was discarded and not returned to the manufacturer for evaluation, thus no returned product investigation was performed.Block h6: per the ifu, cardiac perforation is a known adverse effect of the procedure.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) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that a verisight catheter was used in a therapeutic ep structural heart procedure.The catheter was delivered over a non-philips guidewire that was placed near the left atrial appendage (laa).After the atrial septum was dilated, the catheter was advanced to the left atrium when the patient¿s blood pressure dropped.An effusion was detected via transesophageal echocardiography (tee), and a microscopic perforation was noted in the laa.The patient was transferred to the or to surgically repair the perforation.This adverse event is being submitted for the verisight catheter, in use in the area when a perforation occurred, requiring surgical intervention.There was no alleged malfunction of the verisight catheter during the procedure.

• Brand Name: VERISIGHT PRO INTRACARDIAC ECHOCARDIOGRAPHY CATHETER
• Common Device Name: CATHETER, IMAGAING, ULTRASOUND
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 19986574
• Report Number: 3008363989-2024-00049
• Device Sequence Number: 11869933
• Product Code: OBJ
• UDI-Device Identifier: 00845225003036
• UDI-Public: (01)00845225003036(11)240129(17)250129(10)0303103900
• 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): 08/14/2024

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: 01/29/2025
• Device Model Number: VSICE3D
• Device Catalogue Number: VSICE3D
• Device Lot Number: 0303103900
• 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: 07/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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: 9F: INTRODUCER SHEATH, UNK MFG; BOSTON SCIENTIFIC: VERSACROSS GUIDEWIRE, SIZE UNK; PHILIPS: EPIQ ULTRASOUND SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown