MAUDE Adverse Event Report: VOLCANO CORPORATION EAGLE EYE PLATINUM RX DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	85900P
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h3: the eagle eye platinum catheter was returned without the distal section and the non-philips guidewire.Visual inspection found a stretched inner member and distal shaft, resulting in broken microcables, but contained within the shaft.Additionally, it was confirmed that the separated distal section occurred post procedure.Block h6: the probable cause of the reported failure (removal as a system) is due to damage 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.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks e1 & g2: country is china.Blocks h3 & h6: the eagle eye platinum catheter was not returned; thus, no 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.
Event or Problem Description
It was reported that an eagle eye platinum catheter was used in a therapeutic coronary procedure in the proximal lad.While advancing the catheter over the non-philips guidewire, resistance was encountered.The catheter got stuck on the guidewire; therefore, was removed as a system.A new catheter and a guidewire were used to complete the procedure with no patient injury reported.This product problem is being submitted because the eagle eye platinum catheter and a non-philips guidewire were removed as a system.There is potential for harm if it were to recur.

• Brand Name: EAGLE EYE PLATINUM 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 23888236
• Report Number: 3008363989-2025-00166
• Device Sequence Number: 4771124
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)240817(17)260817(10)0303270201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092596
• 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): 02/04/2026

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 Expiration Date: 08/17/2026
• Device Model Number: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 0303270201
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2024
• 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: ASAHI: 0.014", SION GUIDE WIRE.; CORDIS: 6F, INTRODUCER SHEATH.; PHILIPS: INTRASIGHT CONSOLE.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian