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	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a2-a5: 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 italy.Block h3 & h6: based on the photo received of the eagle eye catheter, the tip separation was confirmed.The eagle eye catheter was not returned for evaluation, thus the cause of the tip separation could not be established.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 st catheter was used in a diagnostic coronary procedure in a moderately calcified mid lad.During removal, resistance was noted and the distal tip became detached within the non-philips guiding catheter.Therefore, the eagle eye catheter and guiding catheter were removed as a system.The procedure was completed with another eagle eye catheter.No patient injury reported.This product problem is being submitted due to the tip separation, potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Blocks d9 & h3: eagle eye catheter was returned for evaluation.Block h3: the eagle eye catheter was returned with the separated distal portion.Visual inspection found the scanner body had separated from the proximal fillet.At the location of separation, sharp edges of non malleable material was observed.Block h6: the probable cause of the separated distal portion is damage during removal/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.

• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 800228-4728
• MDR Report Key: 18384244
• Report Number: 3008363989-2023-00059
• Device Sequence Number: 16813073
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)230508(17)250508(10)0302894792
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 05/08/2025
• Device Model Number: 85900PST
• Device Catalogue Number: 85900PST
• Device Lot Number: 0302894792
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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: ABBOTT: BALANCE MIDDLEWEIGHT GUIDEWIRE, SIZE UNK; MEDTRONIC: 7F LAUNCHER GUIDE CATHETER; TERUMO: 7F DESTINATION INTRODUCER SHEATH
• Patient Sex: Unknown