MAUDE Adverse Event Report: PHILIPS VOLCANO VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information of id, weight, ethnicity and race have been unsuccessful to date.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.The implant or explant dates are not applicable to this device.The returned device was visually and microscopically inspected.The distal coil and pressure sensor was returned separated.The proximal coil was stretched out and tangled.The microcables at the pressure sensor were severed.The proximal coil and its core wire were detached from the pressure sensor.The proximal coil was almost entirely stretched.A twist in the proximal coil was observed.No missing material was observed at the severed microcables.All pieces of the device were accounted for and no missing material was observed.The probable cause of the reported failure was mechanical strain, as evidenced by the proximal coil being stretched and detached from the pressure sensor housing.The investigation was unable to conclusively determine when and how the damage occurred.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, the tip of the manufacturers device broke off in the artery and was retrieved using a snare device (another manufacturers device).No further intervention was required.The dr.Decided not to use another device.Vessel: proximal-mid lad (left anterior descending artery) intermediate tortuously and calcification.This adverse event is being submitted because additional intervention was required to remove the manufacturer's device.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: the initial report submitted 07/01/2020 had an inadvertent entry error of 06/13/2020.Correct date is 06/11/2020.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to correct an inadvertent entry error in g4, the date received by manufacturer (becomes aware date).
Additional Manufacturer Narrative
Block g: the supplemental report #1 submitted on 3/7/2021 had an inadvertent entry error of 2/5/2021.Correct date is 6/11/2020.

• Brand Name: VERRATA PLUS PRESSURE GUIDE WIRE, 185 CM STRAIGHT TIP
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business park; b37; alajuela ; CS
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 10222468
• Report Number: 2939520-2020-00017
• Device Sequence Number: 573669
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)230228(10)0301849866(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161887
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020
• 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: 02/28/2023
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301849866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 06/13/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 06/11/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 03/07/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005