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	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a3b, a4, a5 & a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the visions pv.018 catheter was returned for evaluation.Visual inspection found a lifted expanded single lumen (esl) with missing material.Additionally, internal damage (bent) was observed on the scanner.During functional testing, the catheter failed the wire bond, apt, and image tests.Block h6: the probable cause of the catheter fault detected is due to use handling as evidenced by the damage scanner and damaged/missing esl.Strain, impact, and forces associated with use can affect the integrity of the electrical connections within 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 in the mid sfa.After the first run, a catheter fault was detected.The procedure was completed with a new catheter.No patient injury reported.During the device evaluation, missing material from the expanded single lumen (esl) tubing was observed.This product problem is being submitted due to missing material.There is potential for harm if it were to recur.

• 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: diana melliza galvez ; 3721 valley centre drive #500; san diego, CA 92130 ; 510933-4541
• MDR Report Key: 22337056
• Report Number: 3008363989-2025-00086
• Device Sequence Number: 8930420
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)250121(17)270121(10)0303381106
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0303381106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• 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: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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: COOK: 6F INTRODUCER SHEATH; PHILIPS VOLCANO: INTRASIGHT MOBILE; ROTAREX: 0.018 GUIDEWIRE
• Patient Age: 58 YR
• Patient Sex: Female