MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION VISIONS PV.018 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	86700
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Ivus catheter tip broke off in patient¿s left arm, requiring cut-down to retrieve.We attempted to advance an ivus catheter over the wire, but wire wrap occurred, and the catheter was unable to be withdrawn from sheath and caught within the soft tissue of the percutaneous access.Manufacturer response for volcano visions pv.018 digital ivus catheter, (brand not provided) (per site reporter).Customer service was contacted, and event filed.Requested pictures instead of returning device.

• Brand Name: VISIONS PV.018 DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 17197515
• Report Number: 17197515
• Device Sequence Number: 5440776
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)221220(17)241220(10)0302787597
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/20/2023
• Report Date (Section F): 06/20/2023

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: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0302787597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2023
• 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: Other
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White
• Date Report Sent to FDA: 06/20/2023