MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION PIONEER PLUS; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	PPLUS120
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
While being used inside the patient by the physician, the end of the device was found to be separated from the whole.The distal piece was briefly retained, but able to be retrieved by the physician endovascularly.While performing the procedure, the physician elected to use the volcano ivus system with pioneer-plus intravascular us guided re-entry catheter.While using the device, it was identified that the distal end had come apart from the device itself and was located inside the patient.The physician was able to use an endovascular snare to retrieve the retained distal end from inside the patient.The complete removal of any remaining pieces was verified under fluoro x-ray.The device and all the pieces were removed from the sterile field and put in a package for reporting.

• Brand Name: PIONEER PLUS
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 18939720
• Report Number: 18939720
• Device Sequence Number: 6760686
• Product Code: ITX
• UDI-Device Identifier: 00845225002565
• UDI-Public: (01)00845225002565(11)231031(17)251031(10)5608355
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024
• Report Date (Section F): 03/19/2024

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 Model Number: PPLUS120
• Device Catalogue Number: PPLUS120
• Device Lot Number: 5608355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 03/19/2024