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

Model Number	014R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a visions pv.014p rx catheter was used during a therapeutic peripheral procedure in a dialysis patient with pre-existing stent in the brachial vein with some restenosis.During use, the distal portion of the catheter broke off inside the patient likely due to interaction with stent, and embolized to either the right atrium (ra) or right ventricle (rv).A snare was used for removal, and imaging confirmed that no device fragments were left in the patient.This adverse event and product problem is being submitted because the visions catheter separated and embolized, requiring additional intervention to remove the device.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a4: weight not available from the facility.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the visions catheter was returned in two pieces.The distal section includes the distal tip, scanner body, and distal shaft portion; measuring approx.21.5 cm in length.The proximal section includes a portion of the distal shaft, proximal shaft, exit port, luer, and catheter connector; measuring approx.134.2 cm in length, to the end the of the working length.Visual inspection found a damaged guidewire exit port and a stretched distal shaft.At the location of separation, the microcables and core wire were exposed, resulting in sharp edges observed.The overall catheter length (155.7 cm) is above the expected working length (148-152 cm), due to the stretched distal shaft.Block h6: the probable cause of the separation during use/handling of the device is the interaction between the catheter and the existing stent.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.

• 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: diana melliza galvez ; 3721 valley centre drive #500; san diego, CA 92130 ; 510933-4541
• MDR Report Key: 22091975
• Report Number: 3008363989-2025-00067
• Device Sequence Number: 8060317
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)250227(17)270227(10)0303417790
• 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
• 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: 014R
• Device Catalogue Number: 014R
• Device Lot Number: 0303417790
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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: BOSTON SCIENTIFIC: 0.014" GUIDE WIRE.; COOK: 6F INTRODUCER SHEATH.; PHILIPS: INTRASIGHT CONSOLE.
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White