MAUDE Adverse Event Report: PHILIPS VOLCANO EAGLE EYE PLATINUM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	85900P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.The eagle eye platinum catheter was not returned for evaluation, thus no returned product investigation was performed.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 severely calcified proximal renal accessory artery.During use, the tip of the catheter got stuck and broke off inside the patient''s body.An embolization occurred on the renal artery; however, there was flow in the embolized vessel.The physician did not try to remove the separated tip or stent it to the vessel wall.He did not think that the retained tip will cause issues if moved down the blood stream.The procedure was completed with no patient injury reported.This adverse event and product problem is being submitted due to the tip separation that was retained in the patient.
Additional Manufacturer Narrative
Block h3: the eagle eye platinum catheter was returned for evaluation.The distal end of the catheter was not returned, which includes the distal tip, distal fillet, and a portion of the scanner body.The returned part of the catheter includes a portion of the scanner, proximal fillet, distal shaft, proximal shaft, luer, connector cable, and connector.Measurement of the returned portion is approximately 156.5 cm from the distal end to the luer, which concludes that the portion that separated is approximately 2.1 cm.At the separated location, visual inspection found the scanner body and flex had sharp edges of non-malleable material.Block h6: the probable cause of the tip separation is damage during use.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
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 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 ; 510673-2239
• MDR Report Key: 16526248
• Report Number: 3008363989-2023-00008
• Device Sequence Number: 14776630
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)221021(17)241021(10)0302733430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 10/21/2024
• Device Model Number: 85900P
• Device Catalogue Number: 809746001
• Device Lot Number: 0302733430
• 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: 03/10/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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: UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male