MAUDE Adverse Event Report: VOLCANO S.R.L. EAGLE EYE PLATINUM DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 85900P

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

It was reported that during a lead extraction case, the eagle eye platinum catheter kinked on the guide wire while inserting into the pt's body.The physician noticed the kink while advancing the catheter and removed the wire and catheter together resulting in a loss of guide wire position.All portions of the catheter were accounted for upon removal.Access was from the femoral vein up into the inferior vena cava (ivc).There was no stenosis but rather scar tissue to image around the lead which allowed the physician to mitigate risk in the removal of the lead.The physician did not feel any resistance when advancing or removing the catheter.The physician re-wired using the same wire and completed the procedure without any further problems.There was no report of pt injury or adverse event.The pt was discharged according to the original treatment plan and the pt's condition today is reported to be stable.

Manufacturer Narrative

(b)(4).A clinical assessment was requested from the mfr's clinical affairs with the results summarized below: there was no report of pt injury or adverse event.The pt was discharged according to the original treatment plan and the pt's condition today is reported to be stable.At this time, investigation results are still pending therefore no determination as to the cause of this incident has been made.Although the device was being used in the inferior vena cava (ivc), which generally falls within the device's indications for use, it was clearly being used to visualize pacemaker leads in the cardiac tissue which is not an intended use of the device.Currently, not enough safety data has been reported in support og the use of this device for this indication.No other recent filings have been reported for this failure mode.Given the need for close proximity of the catheter to cardiac tissue in lead extraction cases, the loss of guide wire position is considered high risk than typical peripheral use and it is the position of the company to report such an event.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints have been reported for this failure mode within this lot.This device has not yet been returned to the mfr for eval.A supplemental report will be submitted when the investigation results are available.

• Brand Name: EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO S.R.L.; alajuela ; CS
• Manufacturer (Section G): VOLCANO S.R.L.; coyol free zone and business park; b37; alajuela ; CS
• Manufacturer Contact: denise stearns ; 3721 valley centre dr; ste 500; san diego, CA 92130 ; 8587204178
• MDR Report Key: 3894263
• MDR Text Key: 4422662
• Report Number: 2939520-2014-00010
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2014

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: 08/31/2015
• Device Model Number: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 0127 50001593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: 68 YR
• Patient Weight: 78