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	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.The visions pv catheter was returned in two pieces.The distal section includes the distal tip, scanner body, distal shaft portion, and inner member; measuring approx.20 cm in length.The proximal section includes a portion of the distal shaft, proximal shaft, luer, and catheter connector; measuring approx.138 cm in length, to the end the of the working length.Visual inspection found a damaged guidewire exit port, stretched distal shaft, exposed microcables and core wire, resulting in sharp edges observed.The overall catheter length (158 cm) is above the expected working length (147.5-152.5 cm), due to the stretched distal shaft.The probable cause of the separation is damage during use/handling of the device.Manipulation, strain, impact, and forces associated with handling can affect the integrity of the device.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 during a therapeutic peripheral procedure in a moderately calcified mid-popliteal.During pull back, the catheter became stuck on the non-philips guidewire, which required more effort to remove.However, the distal end of the catheter separated, and both the catheter (including the separated portion) and guidewire were removed as a system.Imaging confirmed that no device fragments were left in the patient.The procedure was completed with a new catheter.No patient injury was reported.This product problem is being submitted because the visions catheter separated.There is a potential for harm if the malfunction 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: diana melliza galvez ; 3721 valley centre drive #500; san diego, CA 92130 ; 510933-4541
• MDR Report Key: 22047687
• Report Number: 3008363989-2025-00062
• Device Sequence Number: 9018177
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)241130(17)261130(10)0303352081
• 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
• Report Date (Section B): 05/19/2025

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 Model Number: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0303352081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2024
• 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: ASAHI: 0.014", MONGO GUIDE WIRE; BOSTON:6F, CATAPULT INTRODUCER SHEATH; PHILIPS: INTRASIGHT CONSOLE
• Patient Sex: Unknown