MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	88901
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a visions pv.035 catheter was used in an emergency therapeutic peripheral procedure.During use, the catheter was recognized by the ivus system but immediately disconnected.The system was restarted twice; however, the problem remained.The procedure was completed with a different device.No patient injury reported.This product problem is being reported because the catheter could not be used during an emergent procedure, resulting in a potential for harm due to the delay of treatment.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks e1 & g2: country is brazil.Blocks h3 & h6: the visions catheter was discarded; thus, no product evaluation 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.

• Brand Name: VISIONS PV .035 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): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: ana tan ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4037
• MDR Report Key: 24507767
• Report Number: 3008363989-2026-00030
• Device Sequence Number: 10416210
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(11)250402(17)270402(10)0303447432
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 88901
• Device Catalogue Number: 88901
• Device Lot Number: 0303447432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: PHILIPS: IVUS SYSTEM; UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown