MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .018 INTRAVASCULAR ULTRASOUND IMAGING CATHETER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 86700

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Attempts to obtain "patient weight" was unsuccessful as the information was unavailable.All reasonably known patient information is included in this report.Additional information obtained indicated resistance occurred after the 2nd ivus run.The catheter was stuck on the wire and both were removed from the body.Once they were removed the doctor noticed the catheter and tip were separated.Both catheter and tip were stuck in place on the wire.The udi number is not applicable to this device as it was manufactured prior to 09-24-2016.The implant or explant dates are not applicable to this device.No physical product investigation was possible as the device has not been returned.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.

Event Description

It was reported the catheter tip was 'frozen" on the wire.Patient's treatment was completed by the procedure.Device was inspected during prep and no damage was observed.Resistance was felt outside the body.The catheter device stuck on the wire.All portions of the device appeared accounted for when it was removed from the patient.Damage was observed when it was removed; it was in 2 pieces, there were no protruding parts.The catheter and guidewire were removed together.There was no patient injury, no adverse events, and no additional medical or surgical intervention required.Patient was discharged as expected in "good" condition.Vessel: common iliac disease, calcified.This event is being reported because there is a potential for harm if the event were to recur.

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.A copy of the facility user report ((b)(4)) was received by the manufacturer on or about 11/14/2017.The user report described the event as follows: "upon the removal of the ivus catheter, the tip of the catheter was noted to be unattached from the body/shaft of the catheter." the user report information is consistent with the information previously received and reported in the initial report by the manufacturer on 11-01-2017.Device name was corrected to indicate product as labeled.Manufacturer name, city and state were corrected to indicate the site of manufacture.Updated to indicate the date the device was received by the manufacturer.The returned device was visually and microscopically inspected.The floppy tip was broken off and returned on a portion of a third party guide wire with the inner member intact.The distal fillet was intact and no portions were missing.There was a bulge on the floppy tip, and the floppy tip was flared on the distal end.The device was visually and microscopically inspected for a second time following decontamination.The bulge on the floppy tip was measured to be 5 mm from the distal end of the floppy tip.The mandrel was inserted into both the device and the separated portion of the distal tip and inner member.The mandrel was advanced through both portions without encountering any resistance.The probable cause of the failure is damage during use as evidenced by the wrinkling on the floppy tip and separation.There were no observations with the device that could have feasibly contributed to the reported failure.Coding updated to indicate method and conclusion codes.There were no other coding changes.The instructions for use (ifu) cautions, do not advance the guide wire against significant resistance.If binding occurs between the catheter and guide wire occurs while inside the patient, carefully remove both the wire and catheter and do not use.If resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath/guide catheter) at the same time.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 report is being submitted to provide device analysis on the returned device and additional information received post submission of the initial report on 11-01-2017; and to correct information as applicable.

• Brand Name: VISIONS PV .018 INTRAVASCULAR ULTRASOUND IMAGING CATHETER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: tom brennan ; 3721 valley centre dr ste 500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6995380
• MDR Text Key: 91367467
• Report Number: 2939520-2017-00081
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 86700
• Device Catalogue Number: K8886700
• Device Lot Number: 0003 20044627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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 Age: 79 YR