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

Model Number	014R
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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 from the facility.Blocks b6 & b7: no information available from the facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions pv.014p rx 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.014p rx catheter was used in a therapeutic peripheral procedure in the proximal sfa.When attempting to cross a severely calcified lesion, the catheter became kinked.Thus, the catheter and guidewire were removed as a system.A new catheter was used to complete the procedure with no patient injury reported.This product problem is being submitted because the visions catheter and guidewire were removed as a system.There is potential for harm if this were to recur.
Additional Manufacturer Narrative
Blocks d9 & h3: the visions pv.014p rx catheter was returned for evaluation.Block h3: the visions pv.014p rx catheter was returned without the guidewire.Visual inspection found a zipper tear at the guidewire exit port and a bent proximal shaft.No functional testing performed.Block h6: the probable cause of the reported failure is damage during use/handling of the device.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: catherine eaton ; 3721 valley centre drive #500; san diego, CA 92130 ; 303453-3407
• MDR Report Key: 22467893
• Report Number: 3008363989-2025-00092
• Device Sequence Number: 19857757
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)250429(17)270429(10)0303463913
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 0303463913
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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: GUIDE CATHETER, MFG AND SIZE UNK.; GUIDEWIRE, MFG AND SIZE UNK.; INTRODUCER SHEATH, MFG AND SIZE UNK.; PHILIPS VOLCANO: INTRASIGHT SYSTEM.
• Patient Sex: Unknown