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

Model Number	85900P
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the eagle eye catheter and foreign material were returned for evaluation.Visual inspection found no unusual characteristics of the catheter.The foreign material was analyzed using an optical microscope.Results show that it was cotton thread material that is not used during the eagle eye manufacturing build.During functional testing, a guidewire was inserted through the catheter lumen and no resistance was encountered.Block h6: based on the device evaluation, the cotton thread material is not part of the eagle eye manufacturing build; therefore, the cause could not be established.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 catheter was used for a coronary procedure in the distal rca.During use, resistance was encountered and the catheter could not pass the lesion; therefore, removed from the patient.Upon removal, a thread like material, approx.1 cm in length was observed coming out of the catheter rapid exchange port.A new catheter was used to complete the procedure with no patient injury reported.This product problem is being submitted in abundance of caution because a foreign material was found on the catheter; potential for harm.

• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 24645562
• Report Number: 3008363989-2026-00048
• Device Sequence Number: 9876482
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)251127(17)271127(10)0303644750
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 0303644750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2025
• 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: SAMURAI GUIDEWIRE, SIZE UNK; PHILIPS VOLCANO: INTRASIGHT SYSTEM; TERUMO: 6F GLIDESHEATH INTRODUCER SHEATH
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White