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

Model Number	014R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block b6: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions catheter was not returned, thus no 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 visions pv.014 rx catheter was used in a peripheral therapeutic procedure in a severely tortuous proximal iliac vessel.During removal, the catheter got stuck on a non-philips guidewire and could not be removed.Therefore, a lot of force was applied, but approx.15 cm from the rx port to the tip separated within the non-philips sheath.The separated portion was stuck on the guidewire, and all were removed together.Fluoroscopy confirmed no device fragment was left inside the patient.The procedure was completed with angioplasty.No patient injury reported.This product problem is being submitted due to shaft separation; potential for harm.
Additional Manufacturer Narrative
Blocks d9 & h3: the visions pv.014p rx catheter was returned for evaluation.Block h3: the visions pv catheter was returned in two pieces, along with a non-philips guidewire that was intact to the distal section and could not be removed.The distal section includes the distal tip, scanner body, and portion of the distal shaft; measuring approximately 19 cm in length.The proximal section includes the remainder of the distal shaft, proximal shaft, exit port, luer, and catheter connector; measuring approximately 133 cm in length.Visual inspection found damage to the distal shaft, exit port, and a slightly bent core wire.At the location of the separation, the core wire and microcables were exposed, resulting in sharp edge observed.The total length combined is 152 cm, which is within the measurement spec of 147.5 - 152.5 cm.Block h6: based on the complaint details and evaluation, the probable cause of the device separation is due to the force applied by the user.Strain, impact, and forces associated with use can affect the integrity of the device.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.

• 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: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 23930009
• Report Number: 3008363989-2025-00171
• Device Sequence Number: 21023609
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)251106(17)271106(10)0303620879
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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 Model Number: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0303620879
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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: BOSTON SCIENTIFIC: 0.014" CHOICE PT GUIDE WIRE.; COOK: 6F INTRODUCER SHEATH.; PHILIPS: INTRASIGHT MOBILE.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American