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	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2 & a3b: not available from facility.Block b6: not available from facility.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions catheter was not returned, 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.018 catheter was used in a diagnostic procedure.During use, a weird picture was displayed, making the decision to swap for another catheter.However, upon removal, it was observed that the tip separated.A new visions catheter was used to complete the procedure with no additional intervention.No patient injury reported.This product problem is being submitted because the visions catheter tip separated.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block h3: the visions pv.018 catheter was returned without the distal portion of the floppy tip.The returned section includes the proximal portion of the floppy tip, scanner body, expanded single lumen (esl), distal shaft, luer, cable connector, and connector.The floppy tip length specification is 12 mm ±1 mm.The returned portion of the floppy tip measured approx.4 mm, which concludes that approx.8 mm (0.8 cm) was not returned.Block h6: the probable cause of the tip separation is likely due to handling during use.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 .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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 23997752
• Report Number: 3008363989-2026-00005
• Device Sequence Number: 13317714
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)250610(17)270610(10)0303488780
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 0303488780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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 WIRE, MFG AND SIZE UNK; INTRODUCER SHEATH, MFG AND SIZE UNK; INTRODUCER SHEATH, MFG AND SIZE UNK; PHILIPS: SYSTEM CONSOLE, MODEL UNK
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White