MAUDE Adverse Event Report: VOLCANO CORPORATION VERISIGHT PRO INTRACARDIAC ECHOCARDIOGRAPHY CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	VSICE3D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pericardial Effusion (3271)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a4: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the verisight pro catheter was discarded and not returned to the manufacturer for evaluation, thus no returned product investigation was performed.Blocks h7 & h9: 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 pro (ice) catheter was used on a patient with chronic anticoagulation and with amyloid angiopathy scheduled for left atrial appendage (laa) closure to avoid long term anticoagulation.Ice was inserted via left femoral approach, and anticoagulation with heparin was started.Based on preop ct scans, a lower septal stick was decided because it would have been the best angle to deliver the watchman device into the laa.Transeptal was uneventful, the wire crossed, and the hole was dilated.The ice was difficult to get across the interatrial septum due to tortuosity, and after multiple attempts, a second interatrial stick was performed that was placed higher.A ¿swirling¿ in the distal field of the ice was noted, but could not exactly be determined.The transeptal was performed, wire was placed in the left atrium, and the watchman was delivered in the laa.When the tee was turned on to check the device positioning, at that point it was clear that the ¿swirling¿ was in fact a left atrial intramural hematoma, which measured 6.4 x 3.7 cm.However, it did not interfere with mitral valve function.During the second transeptal and positioning of the watchman, there was no pericardial effusion on either the ice or tee.The procedure was discontinued, anticoagulation was reversed, and the watchman was removed.The patient''s blood pressure always remained stable.About 30 minutes later a small pericardial effusion was noted and a pericardiocentesis was performed.Approximately 250 cc of dark blood was removed.The patient was never hemodynamically unstable and never had any evidence of tamponade.The patient was admitted to icu for observation and the pericardial effusion never recurred.Additionally, it was reported that the intramural hematoma became smaller.While in the hospital, anticoagulation was restarted and follow-up echoes were stable.The patient was discharged on half dose anticoagulation, and rescheduled to repeat watchman procedure in 6 weeks.This adverse event is being submitted in abundance of caution because a hematoma and pericardial effusion occurred.Multiple devices were in use, and it could not be determined which device caused or contributed to the adverse event.There was no alleged malfunction with the verisight pro (ice) catheter.

• Brand Name: VERISIGHT PRO INTRACARDIAC ECHOCARDIOGRAPHY CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 19356193
• Report Number: 3008363989-2024-00031
• Device Sequence Number: 6499997
• Product Code: OBJ
• UDI-Device Identifier: 00845225003036
• UDI-Public: (01)00845225003036(11)230703(17)240703(10)0302941758
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 07/03/2024
• Device Model Number: VSICE3D
• Device Catalogue Number: VSICE3D
• Device Lot Number: 0302941758
• 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: Not provided
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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: CONSOLE: EPIQ SYSTEM; GUIDEWIRE MFG AND SIZE UNK; INTRODUCER SHEATH MFG AND SIZE UNK
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White