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

Model Number 85900P

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Foreign Body Embolism (4439)

Event Date 02/09/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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 ; 510673-223
• MDR Report Key: 16526248
• MDR Text Key: 311124558
• Report Number: 3008363989-2023-00008
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)221021(17)241021(10)0302733430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male