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 10/07/2020

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 identifier, 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.The implant or explant dates are not applicable to this device.Not applicable for this device.Device was not returned for analysis.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.

Event Description

It was reported during a diagnostic peripheral procedure when pulling back the manufacturers device the tip of the device broke off in the patient.Attempts to retrieve were unsuccessful, a stent was placed in the brachiocephalic arch.This adverse event is being submitted because the tip of the manufacture¿s wire separated in the patient and additional medical intervention was required to stent the separated portion of the device in situ.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: all reasonably known patient information is included in this report.Block h3: the device was visually and microscopically inspected, damage was observed.The scanner body and floppy tip were missing from the catheter shaft.The distal end of the esl (expanded single lumen) had rough edges and portions were missing with the detached scanner body.A small portion of inner member material was also missing with the detached scanner body.The microcables were severed and visible as a result of the torn esl.The inner member was torn.The probable cause of the reported tip separation is damage in use, likely from an excessive pulling force, as evidenced by the observed stretched and twisted distal end of the damaged catheter shaft.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 and additional information received.

• 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: 10728473
• MDR Text Key: 212781841
• Report Number: 2939520-2020-00029
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)220831(10)0302006758(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: 10/07/2020

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: 0302006758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 115