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

Model Number	VSICE3D
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2 & a4: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the verisight catheter was not returned for evaluation, thus no returned product investigation was performed.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 to guide an intraprocedural implant for left atrial appendage closure.During use, when switching back from the x5-1c transthoracic probe to verisight, the image became blurry and unusable.The procedure was postponed and will be rescheduled with use of general anesthesia and tee.No patient injury reported.This product problem is being reported due to the poor image quality, resulting in a delay of procedure, potential for harm.
Additional Manufacturer Narrative
Block b5: based on the device evaluation, this event has been determined as no longer reportable.Blocks d9 & h3: the verisight catheter was returned for evaluation.Block h3: visual inspection found no usual characteristics of the catheter.During functional testing, the catheter was connected to a laboratory epiq system and was able to be recognized.The distal end of the catheter was placed in a phantom target, which produced and maintained a uniform distribution of echo intensity with no error messages or artifacts observed.Block h6: based on the device evaluation, the reported complaint could not be confirmed as the device performed as intended.Therefore, the probable cause of the poor image experienced by the user could not be determined by the investigation.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
The initial mdr was reported for a poor image that the patient would be brought back for general anesthesia and tee.However, based on the device evaluation, this is no longer reportable since the catheter produced and maintained a uniform distribution of echo intensity.The catheter performed as intended; therefore, there is no potential for harm for delay of treatment with recurrence.

• 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: 20467567
• Report Number: 3008363989-2024-00092
• Device Sequence Number: 18010385
• Product Code: OBJ
• UDI-Device Identifier: 00845225003036
• UDI-Public: (01)00845225003036(11)240108(17)250108(10)0303087531
• 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,Followup
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2025
• Device Model Number: VSICE3D
• Device Catalogue Number: VSICE3D
• Device Lot Number: 0303087531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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: BOSTON SCIENTIFIC: 10F WATCHMAN INTRODUCER SHEATH.; PHILIPS: EPIQ SYSTEM.; UNK MFG AND SIZE: GUIDE CATHETER.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White