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	Foreign Body In Patient (2687)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a2: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the visions catheter was returned without the distal section, which includes the distal tip, scanner, and expanded single lumen.The returned section includes the shaft, luer, and connector; measuring approx.135.4 cm.The overall working length measurement spec is 135-139 cm, which concludes that approx.1.2 cm was retained in the patient (based on returned portion).Visual inspection found a damaged guidewire exit port.Block h6: the probable cause of the separation is damage during use/handling due to the catheter getting caught on calcium.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 catheter was used in a therapeutic peripheral procedure to treat a severely calcified distal popliteal.During removal, the catheter tip got caught on an iliac stent and broke off inside the patient.Attempts to retrieve the tip with a snare was unsuccessful; therefore, the patient was referred to surgery.However, due to the location where the tip got dislodged and unable to travel or embolize, the tip was retained in the patient.This adverse event and product problem is being submitted because the visions catheter tip separated inside the patient, requiring intervention, but retained in patient.

• 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: 22092686
• Report Number: 3008363989-2025-00068
• Device Sequence Number: 7885799
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)250203(17)270203(10)0303396125
• 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): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0303396125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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: ABBOTT: 0.018" HI-TORQUE COMMAND GUIDEWIRE; PHILIPS VOLCANO: INTRASIGHT SYSTEM; TERUMO: 5F PINNACLE INTRODUCER SHEATH
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White