MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	81234
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2020
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 have been unsuccessful.Facility declined to provide the information.All reasonably known patient information is included in this report.Additional information received indicated that the manufacturer's device was used on the venus side of fistula to push catheter around astola with no resistance going in.Got up to shoulder and felt resistance on pullback and tip got dislodged near arteriole anastomosis experienced some image loss.Dr.Tried to go in with multiple wires and snares and dr.Was unable to obtain tip.Sent patient to get tip removed surgically.The patient's status is noted to be good with improved function of fistula.Device was discarded at the customer site and not returned to manufacturer for analysis.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 diagnostic peripheral procedure the tip of the manufacture's device separated inside the patient.This adverse event is being submitted because the manufacture's device separated in the patient and additional medical and surgical intervention were required.
Event or Problem Description
This follow-up supplemental report #1 is being submitted to correct an inadvertent entry error in block g4 in the initial report submission.
Additional Manufacturer Narrative
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: correction; entry error in initial mdr aware date, corrected from (b)(6) 2020 to (b)(6) 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
Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Block g4: the supplemental report submitted (b)(6) 2020, had an inadvertent entry error of (b)(6) 2020.Correct date is (b)(6) 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 #2 is being submitted to correct an inadvertent entry error in g4.The date received by manufacturer (becomes aware date).
Additional Manufacturer Narrative
Block g: corrected date from 2/5/2021 to 2/19/2020.

• Brand Name: VISIONS PV .035 DIGITAL IVUS 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: 9883816
• Report Number: 2939520-2020-00011
• Device Sequence Number: 16780720
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(17)220131(10)0301831866(90)989609000971
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• 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,Followup
• Report Date (Section B): 02/19/2020
• 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: 01/31/2022
• Device Model Number: 81234
• Device Catalogue Number: 400-0200.272
• Device Lot Number: 0301831866
• 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: 02/24/2020
• Supplement Date Received by Manufacturer: 02/26/2020; 02/05/2021; 02/19/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 03/30/2020; 03/07/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005