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

Model Number	85900P
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coronary therapeutic procedure, the eagle eye platinum catheter kinked and could not be removed from the non-manufacturer guide catheter.The entire system was removed as a unit.No patient injury reported.This product problem is being submitted because the eagle eye platinum catheter was removed as a system that can result in a potential for harm.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Patient age, gender, weight, ethnicity and race: no information available.Patient history: no information available.Products: not applicable for this device.Implant and explant date: not applicable for this device.The eagle eye platinum catheter was discarded by the facility, thus no returned product investigation was performed.Adverse event/action: do not apply to this submission.

• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14428765
• Report Number: 3008363989-2022-00028
• Device Sequence Number: 20465682
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)210126(17)240126(10)0302503345
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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: 01/26/2024
• Device Model Number: 85900P
• Device Catalogue Number: 809746001
• Device Lot Number: 0302503345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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
• Patient Sex: Unknown