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

Model Number	86700
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a3-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.Blocks h3 & h6: the visions catheter was not returned for evaluation, 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.018p catheter was used in a therapeutic peripheral procedure.During removal, the catheter became kinked, and the entire system was removed as a unit.The procedure was completed without using ivus.No patient injury reported.This product problem is being submitted because the visions catheter and concomitant devices were removed as a system; potential for harm.
Additional Manufacturer Narrative
D9 and h3: the visions catheter was returned for evaluation.H3: the visions catheter was returned without the non-philips concomitant devices.Visual inspection found no kinks on the catheter; however, a stretched guide wire exit port was observed.During functional testing, a 0.018¿ mandrel was inserted through the distal tip to the exit port and encountered no resistance.The guidewire movement test passed with no issues.H6: the reported complaint of a catheter kink and removed as a unit could not be confirmed.No visible kinks were found and the catheter passed the guidewire movement test.Therefore, the cause could not be established.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 .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: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 21930207
• Report Number: 3008363989-2025-00053
• Device Sequence Number: 9073346
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)240927(17)260927(10)0303297161
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 09/27/2026
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0303297161
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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: GUIDE CATHETER, MFG AND SIZE UNK; MERIT: 0.018", INQUIRE GUIDEWIRE; MERIT: 6F, PSS INTRODUCER SHEATH; PHILIPS: INTRASIGHT MOBILE CONSOLE
• Patient Age: 79 YR
• Patient Sex: Female