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

Model Number	85900PST
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.The eagle eye platinum st catheter was discarded by the facility, thus no returned product investigation was performed.
Event or Problem Description
It was reported that during a therapeutic coronary procedure, during removal of the manufacturer's catheter, it got stuck on the non-manufacturer's wire.Therefore, the entire system was removed as a unit.No patient injury reported.This product problem is being submitted due to removal as a system.There is a potential for harm if the malfunction were to recur.

• Brand Name: EAGLE EYE PLATINUM ST
• 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 pa; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 13698873
• Report Number: 3008363989-2022-00012
• Device Sequence Number: 6287124
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)220103(17)240103(10)0302486271
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120697
• 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): 02/10/2022

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: 01/03/2024
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0302486271
• 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: 02/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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 CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown