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

Model Number 85900PJ

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information of id, age, weight, ethnicity and race have been unsuccessful to date.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.The implant or explant dates are not applicable to this device.Device available for evaluation?: not applicable for this device.No information available.(b)(6).

Event Description

This case was reviewed and investigated according to the manufacture¿s policy.It was reported when unboxing the manufacturer's device for use, the tip appeared to be missing.The physician proceeded to perform a diagnostic peripheral procedure using the device.When the radiopaque transducer could not be found under fluoroscopy the physician removed the device and confirmed the transducer was missing.An image was not produced.The transducer was not found inside or outside the patient.It is believed the transducer had not been attached from the beginning.A second of same product was used to complete the procedure.Reportedly, there were no protruding parts, no portion of the device became separated or detached within the patient.There was no status decline, no evidence of an injury nor any required intervention to prevent injury.Vessel: mid sfa (superficial femoral artery), slight tortuous, moderate calcification, 100% occluded.Visual, microscopic inspection and functional testing were performed on the returned device.The distal tip including the distal fillet and the scanner body was separated from the device at the weld legs.The device failed to be recognized by the imaging system and the system displayed a ¿no catheter¿ message.The probable cause of the reported failure is damage in use as evidenced by the scanner body and distal tip separation from the device.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.Per the instructions for use: precautions: the device is a delicate scientific instrument and should be treated as such.Always observe the following precautions: prior to use, carefully inspect the scanner and device body for bends, kinks or other damage.Do not use a damaged or suspected damaged device.Protect the device tip from impact and excessive force.Do not cut, crease, knot, or otherwise damage the device.Do not handle the transducer.This product problem is being submitted because it could not be determined when the tip separated from the manufacture¿s device.There is a potential for harm if the malfunction were to recur.

• Brand Name: EAGLE EYE PLATINUM, JAPAN
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 10497781
• MDR Text Key: 224999633
• Report Number: 2939520-2020-00023
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225001339
• UDI-Public: (01)00845225001339(17)211231(10)0301805478(90)989609001101
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K143701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 85900PJ
• Device Catalogue Number: 400-0200.71
• Device Lot Number: 0301805478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• 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