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

Model Number	85900PST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an eagle eye catheter was used in a therapeutic peripheral procedure.During pullback, the shaft separated but was successfully removed with a snare.Angiography confirmed nothing was left inside the patient.The procedure was completed with another eagle eye catheter with no patient injury reported.This adverse event and product problem is being submitted due to the shaft separation requiring intervention (snare).
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a4: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is japan.Blocks h3 & h6: the eagle eye platinum st catheter was not returned for evaluation, 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.
Additional Manufacturer Narrative
Blocks d9 & h3: the eagle eye platinum st catheter was returned for evaluation.Block h3: the eagle eye catheter was returned in two pieces.The first section includes the distal tip, distal fillet, scanner body, and a portion of the distal shaft (stretched); measuring approximately 23.1 cm in length.The second section includes a portion of the distal shaft, proximal shaft, luer, connector cable, and connector; measuring approximately 135.5 cm in length.Both sections combined is 158.6 cm in total length.The overall spec is 147.5 - 152.5 cm, which aligns with the stretched distal shaft (first portion).Visual inspection found a damaged guidewire exit port and a damaged distal shaft (second portion).At the location of the separation, the microcables and core wire were exposed, resulting in sharp edges observed.Block h6: the probable cause of the separated shaft is due to the excessive force applied to the catheter.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.

• 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: 21040122
• Report Number: 3008363989-2024-00179
• Device Sequence Number: 18041233
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)240904(17)260904(10)0303282703
• 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): 02/13/2025

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 Expiration Date: 09/04/2026
• Device Model Number: 85900PST
• Device Catalogue Number: 85900PST
• Device Lot Number: 0303282703
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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: GUIDE WIRE, MFG AND SIZE UNK.; PHILIPS VOLCANO: INTRASIGHT MOBILE SYSTEM.; TERUMO DESTINATION 6F INTRODUCER SHEATH.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian