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

Model Number 89000

Device Problems Physical Resistance (2578); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer's policy.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.No tests/laboratory data was available.No information was available.Visual and microscopic inspection was performed on the returned device.It was observed the proximal shaft was cut near the end of the telescope distal strain relief, which coincides with the user reporting they decided to cut the catheter off at the proximal shaft for removal.The proximal 52mm of the drive cable and 56mm of the coax were cut from the end of the distal telescoping section.The distal portion of the drive cable was removed from the catheter body.Dried blood was observed at the distal tip and at the distal shaft window where the flushing exit port is located.There was no damage on the distal tip and exit port.A slight tear was observed in the distal end of the monorail.The guidewire movement test was performed and the device passed.A 0.014" mandrel from our lab was used and it was threaded through the distal end of the catheter and out the exit port without any resistance.The reported failure "resistance" was not duplicated during the device evaluation.We were unable to conclusively determine how and why the reported failure occurred.The device performed as intended.The damage observed on the proximal portion of the device was caused by the user during attempts to remove the device.The instructions for use (ifu) warn: 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.Exercise care when advancing the revolution catheter distal to a deployed stent.The short monorail segment can result in exposure of the guide wire to the stent struts.Care should be taken when advancing or re-advancing a guide wire or catheter through a deployed stent.A guide wire may exit between stent struts when crossing or re-crossing a stent that is not fully apposed to the vessel wall.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 the catheter/guide wire, catheter tip separation, and/or stent dislocation.Never use force to advance the catheter.Use caution when removing the catheter over the guide wire from a stented vessel to minimize patient risk.In instances where the device has crossed a deployed stent, care should be taken when retracting the device to ensure that entanglement does not occur.Fluoroscopy should be used to monitor guide wire position with respect to the imaging catheter and the stent; at no time should the imaging catheter be retracted if there is evidence of guide wire prolapse or if significant resistance to withdrawal is experienced.If either of these events occur, advance the imaging catheter distal of the stent and then carefully remove the whole system under the guidance of fluoroscopy.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.To date, no other complaints were reported for this same failure mode within this lot.This complaint will be monitored as part of complaint data analysis.

Event Description

It was reported that during removal the catheter got stuck with a placed stent in the left anterior descending artery (lad).The catheter was pushed and torque was applied unsuccessfully to release the device.A balloon catheter was inserted though the guidewire (gw) but it could not reach where it was stuck.A micro-catheter was inserted through the gw but it could not reach either.The user decided to cut the catheter off at the proximal shaft and removed the proximal part of the catheter first.Next, the physician inserted and delivered a gw over the stuck point and tried to insert a 4fr gc, but it could not put in the 6fr gc.The physician inserted the 4fr gc contralaterally into the lmt by cannulation and delivered the gw and the micro catheter inside the stent.The micro catheter successfully unstuck the device and the distal part of the catheter was removed.The device was inspected during prep and no damage was observed.All portions of the device appeared accounted for after removal from the patient.Treatment was completed by the procedure.There was no patient harm and no surgical intervention was required.The patient was discharged as expected in "stable" condition.This case is being reported as additional intervention was required to remove the device from the patient.

• Brand Name: REVOLUTION 45MHZ IVUS IMAGING CATHETER
• Type of Device: CATHETER, ULTRASOUD, 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: 5992078
• MDR Text Key: 56097202
• Report Number: 2939520-2016-00070
• 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: 09/01/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 89000
• Device Catalogue Number: 805000001
• Device Lot Number: 0035 50068613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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
• Patient Outcome(s): Required Intervention