MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .014P RX; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 014R

Device Problem Material Separation (1562)

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

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email.The implant or explant dates are not applicable to this device.Not applicable for this device.Device evaluation anticipated, but not yet begun.Do not apply to this submission.The instructions for use (ifu) cautions: prior to use, carefully inspect the scanner and catheter body for bends, kinks or other damage.Do not use a damaged or suspected damaged catheter.Protect the catheter tip from impact and excessive force.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 manufactures policy.It was reported during a planned diagnostic peripheral procedure, the distal portion of the manufacturers device separated inside the patient.A snare was used to remove the portion.This adverse event is being submitted because additional intervention was required to remove the separated portion of the manufactures device.

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, functional testing was performed.A portion of the distal shaft was detached from the overall device, the microcables and the inner member were exposed, no missing additional material.There was a kink and a flattened portion on the distal shaft, but no rough/sharp edges detected.The remaining distal shaft (proximal to the separation) the microcables and the inner member were exposed, there was zippered tear observed on the distal shaft and inner member starting from the guidewire exit port to the detached section, rough edges of malleable shaft material were observed.The probable cause of the reported ¿the distal 10 cm portion of the catheter separated from the rest of the catheter¿ condition is due to mechanical strain.Strain, impact, and forces associated with use can affect the integrity of the device.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: VISIONS PV .014P RX
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11248535
• MDR Text Key: 233031343
• Report Number: 2939520-2021-00006
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)200928(17)220928(10)0302044372
• Combination Product (y/n): Y
• PMA/PMN Number: K152829
• 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: 12/29/2020

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: 09/28/2022
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302044372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention