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	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block e1 & g2: country is japan.Block h3 & h6: the eagle eye platinum catheter was not returned for evaluation; thus, no returned product investigation was performed.Blocks h7 & h9: 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 peripheral procedure.During advancement to in-stent restenosis (isr), the catheter became stuck within the stent.To remove, the shaft was cut and a non-philips guideliner was used to release the catheter.Upon removal, a burr at the catheter guidewire exit port was observed.Fluoroscopy confirmed that no device remnants were left inside the patient.The procedure was completed with no patient injury reported.This adverse event and product problem is being submitted because the eagle eye platinum catheter was entrapped, and additional intervention was required to remove the device.
Additional Manufacturer Narrative
Blocks d9 & h3: the eagle eye catheter was returned for evaluation.Block h3: the eagle eye catheter was returned without the proximal shaft, luer, connector, and connector cable.Visual inspection of the returned portion found a stretched guidewire exit port.This observation aligns with the reported complaint that the shaft was intentionally cut in order to remove from the patient, and upon removal, damage was noted at the guidewire exit port.Block h6: based on the complaint details, the catheter got caught on an existing stent.Per the ifu: use caution when re-advancing a catheter over a guide wire and into a stented vessel.Forceful advancement of the ivus catheter could cause entanglement between the catheter and the stent(s) resulting in entrapment of catheter/guide wire, catheter tip separation, and/or stent dislocation.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: catherine eaton ; 3721 valley centre drive #500; san diego, CA 92130 ; 303453-3407
• MDR Report Key: 21712741
• Report Number: 3008363989-2025-00039
• Device Sequence Number: 18644599
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)241108(17)261108(10)0303335915
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 85900PST
• Device Catalogue Number: 85900PST
• Device Lot Number: 0303335915
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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: GUIDE WIRE, SIZE UNK.; BOSTON SCIENTIFIC: ELUVIA STENT, 6MM.; NIPRO: 6FR 45CM CROSSROADS GUIDE SHEATH.; PHILIPS VOLCANO: INTRASIGHT MOBILE SYSTEM.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian