MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .018 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 86700

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information for age, 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.Additional information obtained indicated device was removed by itself.No resistance was encountered and device was never stuck.After unsuccessfully attempting to remove the separation by snare, the tip of the manufacturer's catheter device was left in the patient, not stented.The remainder of the manufacturer¿s device was removed, and the procedure was completed without another same manufacturer¿s device under fluoroscopy.There was no status decline.Vessel was tortuous but not fully occluded.Patient was discharged as expected in stable condition.The implant or explant dates are not applicable to this device.Not applicable for this device.Device was discarded at the facility and not returned for analysis.Correction/removal #: do not apply to this submission.The instructions for use (ifu) cautions: do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.If binding occurs outside of the patient, remove the catheter and do not use.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.

Event Description

This case was reviewed and investigated according to the manufacture¿s policy.It was reported during a planned diagnostic peripheral procedure, while advancing through the vessel, the tip of the manufacturer¿s device separated and came off from the tip of the shaft.Vessel: mid, av fistula; vessel tortuosity: severe; target lesion: soft tissue this adverse event is being submitted because additional intervention was required to remove the manufacturer's device.

Event Description

This case was reviewed and investigated according to the manufacturer's policy.Internal reference: (b)(4).This follow-up supplemental report #1 is being submitted to report additional investigation findings, to wit: there is no potential for harm if the malfunction were to recur.This complaint was reassessed based on additional information indicating the reported device and adverse event were inadvertently reported in error.There was no patient injury, no status decline, no adverse event, and no unplanned additional medical or surgical intervention reported for this complaint.There is no potential for harm if the malfunction were to recur.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.

• Brand Name: VISIONS PV .018 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 10678598
• MDR Text Key: 211504419
• Report Number: 2939520-2020-00026
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)220831(10)0302006760(90)300004659341
• Combination Product (y/n): Y
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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: 08/31/2022
• Device Model Number: 86700
• Device Catalogue Number: K8886700
• Device Lot Number: 0302006760
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SNARE.
• Patient Outcome(s): Required Intervention