MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	86700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the visions pv.018 catheter was returned without the distal tip.Visual inspection found no unusual characteristics of the device.The distal tip measured approx.3 mm in length.The tip specification is 10-13 mm, which indicates that approx.7-10 mm in length had separated from the catheter.Block h6: the probable cause of the tip separation was likely damaged during removal/handling from the patient.Strain, impact, and forces associated with use 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.018 catheter was used in a peripheral therapeutic procedure.During removal, while passing through the introducer sheath, the catheter distal tip separated.Both the catheter with the distal tip and sheath were removed as a system.The procedure was completed with the visions catheter.No patient injury reported.This product problem is being submitted because the visions distal tip separated; potential for harm.

• Brand Name: VISIONS PV .018 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 21317674
• Report Number: 3008363989-2025-00014
• Device Sequence Number: 20865284
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)240627(17)260627(10)0303233459
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150442
• 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
• Report Date (Section B): 02/05/2025

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: 06/27/2026
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0303233459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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: ABBOTT: COMMAND ES GUIDE WIRE, SIZE UNK; CORDIS: 6F RDC INTRODUCER SHEATH; PHILIPS VOLCANO: CORE MOBILE SYSTEM
• Patient Sex: Unknown