MAUDE Adverse Event Report: PHILIPS VOLCANO EAGLE EYE PLATINUM; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 85900P

Device Problems Entrapment of Device (1212); Material Separation (1562)

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

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).Attempts to obtain patient information are unsuccessful.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.Additional information stated, while navigating the device to the distal periphery, the manufacturers device became stuck in the subclavian vein.To free the device the physician pulled the device back and the transducer stayed in the subclavian area.A retrieval device was used to remove the separated portion of the device and the procedure was ended.No tests/laboratory data was available.Suspect products: no information available.The implant or explant dates are not applicable to this device.Device available for evaluation: not applicable for this device.Device was not returned to manufacturer for analysis.Device was not returned to manufacturer for analysis.Recall & correction/removal number: 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.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.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 case was reviewed and investigated according to the manufacture¿s policy.It was reported during a diagnostic peripheral procedure, the physician was attempting to go to the venous iliac.Physician did not use a long sheath or guide.014 wire; started going across, went further, and when got to the vena cava the catheter angled and broke.The tip broke off and they had to use a snare to retrieve it.Patient stayed overnight but is now fine and was discharged.The procedure was not completed.This adverse event is being submitted because a portion of the manufactures device separated, additional intervention was required to remove the separated portion and patient hospitalization.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer''s policy.Block h3: the device was visually and microscopically inspected.All of the distal shaft(distal tip, scanner, distal and proximal fillet) were detached from the proximal shaft, as result rough edges were observed on the distal and proximal shaft.The microcables were detached and exposed on the proximal and distal shaft.The probable cause of the reported failure is: damage in use, as evidenced by the distal shaft separation.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 #1 is being submitted to advise pertinent device analysis findings.

• Brand Name: EAGLE EYE PLATINUM
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11070377
• MDR Text Key: 225269288
• Report Number: 2939520-2020-00040
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)201030(17)221030(10)0302067216
• Combination Product (y/n): Y
• PMA/PMN Number: K143701
• 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: 12/16/2020

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: 10/30/2022
• Device Model Number: 85900P
• Device Catalogue Number: 809746001
• Device Lot Number: 0302067216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR