MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .014P RX DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	014R
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: no information available from the facility.Blocks b6 & b7: no information available from the facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the visions pv.014p rx catheter was returned without the non-philips guidewire.Visual inspection found a stretched guidewire exit port.During functional testing, the catheter failed the guidewire movement test due to resistance.Block h6: the probable cause of the reported failure is damage during use/handling as evidenced by the failed guidewire movement test.Strain, impact, and forces associated with use can affect the integrity of the device.However, it could not be determined when and how the failure occurred.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 visions pv.014p rx catheter was used in a diagnostic peripheral procedure in a slightly calcified plaque lesion in the mid tp trunk.During advancement, the catheter got stuck on a non-philips guidewire, and the entire system was removed as a unit.A new catheter was used to complete the procedure with no patient injury reported.This product problem is being submitted because the visions catheter and a non-philips guidewire were removed as a system.There is potential for harm if it were to recur.

• Brand Name: VISIONS PV .014P RX DIGITAL IVUS 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: catherine eaton ; 3721 valley centre drive #500; san diego, CA 92130 ; 303453-3407
• MDR Report Key: 22319416
• Report Number: 3008363989-2025-00081
• Device Sequence Number: 21031238
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)230720(17)250720(10)0302954628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: 07/20/2025
• Device Model Number: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0302954628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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: ABBOTT SPARTACORE 0.014 GUIDEWIRE.; COOK MEDICAL 6F INTRODUCER SHEATH.; PHILIPS VOLCANO: INTRASIGHT MOBILE SYSTEM.
• Patient Sex: Unknown