MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA PLUS PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Facility declined to provide patient information.By report, patient discharged without any problem.The implant or explant dates are not applicable to this device.State/prefecture is (b)(6).The returned device was visually and microscopically inspected and damage was observed.The distal coil was stretched and detached in two parts from the wire, exposing the core wire.A portion of the distal coil was stuck into the plastic tube.All parts of the device were present.The sensor was cracked and there no pieces missing.Per note 4, the voluntary medwatch report mw5087715 states: "[a]nd as the pressure wire advanced beyond the crux of the rca, the wire tip was free but the wire no longer advanced.The team attempted to withdraw the wire and re-advance." the instructions for use (ifu) warns: "never advance, torque, or retract a pressure guide wire which meets significant resistance." the ifu also precautions: "the volcano pressure guide wire should not be advanced if resistance is encountered.The wire should never be forcibly pushed into a vessel.Any time that resistance is encountered, the wire should be withdrawn under fluoroscopic guidance." the manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
It was reported during a planned diagnostic coronary procedure, after ifr measurement at lad [left anterior descending artery], the manufacturer¿s device could not be moved in high-lateral.The physician attempted to retrieve the device with a microcatheter resulting in the distal portion separating in the microcatheter.A 6fr guiding catheter and goose neck snare were inserted successfully retrieving the microcatheter and the separated portion of the manufacturer¿s device.This adverse event is being submitted because the manufacture's device separated in the patient and additional intervention was required to retrieve the separated portion of the device.There is a potential for harm if the malfunction were to recur.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 9101888
• Report Number: 2939520-2019-00053
• Device Sequence Number: 2617045
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)220331(10)0301630908(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K161887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301630908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005