MAUDE Adverse Event Report: PHILIPS VOLCANO REVOLUTION 45MHZ IVUS IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	89000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2020
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.Attempts for patient information have been unsuccessful.Additional information obtained indicated the manufacturer's device was used during a pci to lad - x 2 stents mid and ostial.The device had been inserted into the patient 3 times.Ivus was performed post stenting.During pullback resistance was experienced however the device was not stuck.When removing manufacturer's device a short segment of the radio-opaque tip appeared to be avulsed from the shaft.A femoral artery puncture was performed to use a gooseneck snare, which was unsuccessful.On fluoroscopy it could not be located in the neck, head, arms of legs.The patient was hospitalized and monitored over night with no further adverse events reported.No information available.The implant or explant dates are not applicable to this device.Not applicable for this device.6fr terumo radial sheath, guidecath 6fr cordis jl3.5, guidewire rinato asahi.Abbott stent was already deployed.Do not apply to this submission.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.
Event or Problem Description
It was initially reported during a diagnostic coronary procedure when removing the manufacturer¿s catheter device the tip was disconnected and remains in patient.This adverse event is being submitted because a portion of the manufactures device is reported to remain in the patient post-procedure.
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
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: the initial report submitted 05/28/2020 had an inadvertent entry error of 05/21/2020.Correct date is 05/20/2020.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.
Additional Manufacturer Narrative
Block g: the supplemental follow-up #1 submitted on (b)(6) 2021, had an inadvertent entry error of (b)(6) 2021.Correct date is (b)(6) 2020.

• Brand Name: REVOLUTION 45MHZ IVUS IMAGING CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: 10098382
• Report Number: 2939520-2020-00014
• Device Sequence Number: 3407479
• Product Code: OBJ
• UDI-Device Identifier: 00184360000358
• UDI-Public: (01)00184360000358(17)200930(10)0301739600(90)300003738711
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K080891
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2020
• 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: 09/30/2020
• Device Model Number: 89000
• Device Catalogue Number: 805000001
• Device Lot Number: 0301739600
• Was Device Available for Evaluation?: No
• 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: 05/21/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 05/20/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 03/07/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005