MAUDE Adverse Event Report: VOLCANO CORPORATION REVOLUTION 45MHZ IVUS IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 89000

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to philips volcano policy.Additional information obtained indicated the device was not stuck in a lesion, nor was it stuck on any other device.Because the user experienced resistance and removed the device and guidewire as a system, philips volcano is reporting this incident in an abundance of caution.No additional intervention, medical or surgical, was required during the procedure; there were no adverse events reported.The device was not inspected prior to removal from the packaging.No damage was observed during preparation.All portions of the device appeared accounted for and no damage was observed by the user after removal from the patient.Visual and microscopic inspection was performed on the returned device.The revolution catheter was received intact, in that it remained in one piece with no portions determined to be missing.There was no damage on the distal tip and guidewire exit port.A tear was observed in the distal end of the monorail, but the tear did not reach the polyimide ring.Dried blood was observed in the exit port and there was also discoloration in the monorail.The observed damage suggests the device met resistance with the guidewire.Since the guidewire was not returned, an inspection of the guidewire was not possible.The guidewire movement test was performed; a 0.014" mandrel was used to test guide wire movement.It was threaded through the distal end of the catheter and out the exit port without any resistance.During evaluation it was observed the device was received in damaged condition, and was torn at the distal end of the monorail.This was most likely a result of efforts to remove the guidewire from the catheter.Although the guidewire was not returned with the device for investigation, the probable cause of the reported failure was most likely the malfunction of the customer's guide wire and not because of the volcano catheter.However, we were unable to conclusively determine how and when the failure occurred.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints were reported for this same failure mode within this lot.We will continue to monitor these types of complaints.The instructions for use (ifu) warns, "do not advance the catheter if resistance is encountered.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis." the user correctly removed the device after resistance was encountered.

Event Description

It was reported a catheter was used for pci [percutaneous coronary intervention] and inserted into coronary [vessel] several times.At the later stage of the procedure, the gw movement became not smooth [felt resistance] and the user removed the gw and the catheter together as a system.Another same product was used and the procedure was completed.There was no harm or consequence to patient.Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email and phone.All reasonably known patient information is included in this report.

• Brand Name: REVOLUTION 45MHZ IVUS IMAGING CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; b37; alajuela, costa rica ; CS
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 5696630
• MDR Text Key: 46469374
• Report Number: 2939520-2016-00030
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 89000
• Device Catalogue Number: 805000001
• Device Lot Number: 0035 50058508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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