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

Model Number 81234

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  Injury  

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 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 Description

This follow-up supplemental report #1 is being submitted to correct an inadvertent entry error in block g4 in the initial report submission.

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.

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 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).

Manufacturer Narrative

Block g: corrected date from 2/5/2021 to 2/19/2020.

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER
• Type of Device: 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
• MDR Text Key: 196488057
• Report Number: 2939520-2020-00011
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(17)220131(10)0301831866(90)989609000971
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K153094
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,02/19/2020

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
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 02/05/2021; 02/19/2020
• Supplement Dates FDA Received: 03/30/2020; 03/07/2021; 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female