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

Model Number	85900PST
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Blocks b6-b7: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block g2: foreign- china.Blocks h3 & h6: the eagle eye platinum catheter was not returned to the manufacturer; 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.
Event or Problem Description
It was reported that an eagle eye platinum catheter was used in a diagnostic peripheral procedure in a moderately calcified sfa.During use, the catheter would not advance over the guidewire and became difficult to remove; therefore, withdrawn together.A new catheter was used to complete the procedure with no patient injury reported.This product problem is being submitted because the eagle eye platinum catheter and a guidewire were removed as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
Blocks a2, a3a, a4, a5, & a6: age at time of event, sex, weight, ethnicity, and race were provided by the facility.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 eagle eye catheter was returned for evaluation without the non-philips guidewire.Visual inspection found a zipper tear from the guidewire exit port to the distal shaft.Additionally, the inner member is broken, with part of the microcables and core wire protruding from the distal shaft.During functional testing, a mandrel was back loaded into the catheter but failed the guide wire movement test due to resistance noted at the distal tip.Block h6: the probable cause of the experienced failure is likely damaged during use handling.Manipulation, impact and applied pressure associated with use and handling can further 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: EAGLE EYE PLATINUM ST 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 ; 8587204037
• MDR Report Key: 22868761
• Report Number: 3008363989-2025-00106
• Device Sequence Number: 20766620
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)240810(17)260810(10)0303265565
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120697
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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: 08/10/2026
• Device Model Number: 85900PST
• Device Catalogue Number: 85900PST
• Device Lot Number: 0303265565
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 12/10/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/23/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• 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: PHILIPS SYSTEM.; UNK MFG AND SIZE: GUIDE CATHETER.; UNK MFG AND SIZE: GUIDE WIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian