MAUDE Adverse Event Report: Volcano Corporation Visions PV .035 Digital IVUS Catheter; Catheter, Ultrasound, Intravascular

Model Number	88901
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction

• 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): 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 ; +1(858)720-4063
• MDR Report Key: 50453242
• Report Number: 3008363989-2026-00146
• Device Sequence Number: 18582626
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(11)260611(17)280611(10)0303803737
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 0303803737
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2026
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: Asian