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

Model Number 014R

Device Problems Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts to obtain patient information were unsuccessful.Attempts to obtain the patient information were made via email and phone.Tests/laboratory data was available.Other relevant history: no information was available.The implant or explant dates are not applicable to this device.

Event Description

This case was reviewed and investigated according to the manufacturer's policy.It was reported the doctor removed the catheter from the patient and as it was coming off the wire it was peeling.It was described that the catheter looked like it was cut up by a razor.They were able to remove everything from the patient and no harm to the patient.Dr.Had the information from the catheter and was able to complete the procedure with the information they obtained.The catheter went in fine and had no issues with it.Additional information provided the manufacturer's device was inserted into the patient once for a diagnostic peripheral procedure.The device had been inspected prior to the procedure with no visible defects observed.Resistance was observed during the procedure when the device came into contact with a stent placed in a prior procedure.When resistance was met the manufacturers device was pushed through.Imaging was obtained and the procedure was completed with the manufacturer's device.Upon removal of the device from the patients vasculature damage was observed.No adverse events were experienced and the patient was discharged as expected.The device was returned to the manufacturer for analysis.Visual and microscopic inspection were performed on the returned device.There was no evidence of peeling of the manufactures device, however there was a zippered tear in the distal shaft from approximately the middle radiopaque marker to the guide wire exit port.The inner member was bunched and a portion of the microcables and core wire were exposed.The manufactures device was intact with no portions missing.The probable cause of the failure is damage in use as evidenced by the tear in the distal shaft, the bunching of the inner member, the exposed microcables, and core wire.It could not be conclusively determined when or how the cause of the failure occurred.The instructions for use (ifu) precautions the device is a delicate scientific instrument and should be treated as such.Always observe the following precautions: protect the catheter tip from impact and excessive force.When inserting the guide wire both catheter and wire must be straight with no bends or kinks, or damage to inner lumen may occur.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.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.If binding occurs outside of the patient, remove the catheter and do not use.When advancing or re-advancing the catheter over a guide wire and through a stented vessel, in the event that the stent is not fully apposed against the vessel wall, the guide wire / and or catheter may become entangled in the stent between the junction of the catheter and guide wire or within one or more stent struts.This may result in entrapment of catheter/guide wire, catheter tip separation, and/or stent dislocation.Never use force to advance the catheter.Use caution when re-advancing a catheter over a guide wire and into a stented vessel.Forceful advancement of the ivus catheter could cause entanglement between the catheter and the stent(s) resulting in entrapment of catheter/guide wire, catheter tip separation, and/or stent dislocation.Use caution when removing the catheter over the guide wire from a stented vessel to minimize patient risk.If resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath/guide catheter) at the same time.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.Additionally, complaints are monitored by monthly complaint review board process.This event is being reported as there is a potential for harm if the event were to recur.

• Brand Name: VISIONS PV.014P RX DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; alajuela,, B37 ; CS B37
• Manufacturer Contact: melissa pieplow ; 2870 kilgore road; rancho cordova, CA 95670 ; 9163651925
• MDR Report Key: 7543097
• MDR Text Key: 109503724
• Report Number: 2939520-2018-00040
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(17)200430(10)0301425742(90)989609001091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 301425742
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• 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