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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a visions catheter was used in a peripheral therapeutic procedure in a severely calcified mid sfa.During advancement, the distal tip got trapped in the calcified lesion and could not be removed.During removal, force was applied and the distal shaft got dislodged, but an en snare was used to remove from the patient.The procedure was completed with a new visions catheter.No patient injury reported.This adverse event and product problem is being submitted because the visions catheter shaft separated inside the patient, requiring additional intervention for removal.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: not available from facility.Block b6: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is japan.Blocks h3 & h6: the visions catheter was not returned for evaluation; thus, no returned 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.
Additional Manufacturer Narrative
Block h3: the visions catheter was returned in two pieces.The distal section includes the distal tip, scanner body, distal shaft portion; measuring approx.21.1 cm in length.The proximal section includes a portion of the distal shaft, proximal shaft, exit port, luer, and catheter connector; measuring approx.132.1 cm to the end of the working length.Visual inspection found a stretched distal shaft.At the location of the separation, the microcables and core wire were exposed, resulting in sharp edges observed.The total overall length of the usable catheter should be 147.5 - 152.5 cm, which is approx.0.7 cm longer due to the stretched distal shaft.Block h6: the probable cause of the separation was likely damaged during use/handling.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: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 22071232
• Report Number: 3008363989-2025-00064
• Device Sequence Number: 9301484
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)250201(17)270201(10)0303394138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 0303394138
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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: 0.014" GUIDEWIRE, UNK MFG.; PHILIPS VOLCANO: INTRASIGHT MOBILE SYSTEM.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Sex: Unknown
• Patient Race: Asian