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

Model Number 85900P

Device Problems Unable to Obtain Readings (1516); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2014

Event Type  malfunction  

Event Description

While delivering the catheter to the lesion, the user encountered some resistance.The user continued to push the catheter against the resistance until imaging was lost.The device was successfully removed and an identical was used to complete the procedure.No patient injury occurred.

Manufacturer Narrative

(b)(4).The manufacturing documentation was reviewed for the device used in this case and all quality and manufacturing release criteria was met.To date, no other complaints were reported for this same failure within this lot.The device was microscopically inspected and a small scrape was observed near the distal fillet bond.The continuity of the device was tested and initially passed.However, after exposure to fluid in a test fixture, the test indicated a shorted supply lead.An image test was performed.The catheter returned a catheter fault error message.The investigation indicated that the damage at the fillet bond created a gap for fluid to ingress into the device and cause an electrical short between the power and ground microcables.The damage likely occurred when the user attempted to advance the catheter against resistance, causing fluid ingress to damage the electrical components and cause the observed lost image failure.The product ifu warns not to advance the catheter against significant resistance or attempt to force it through tight lumens.Volcano will continue to monitor complaints for this failure mode via our standard complaint review process and data trending activities.

• Brand Name: EAGLE EYE PLATINUM CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCCARICA S.R.L.; alajuela ; CS
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone and business park b37; alaquela ; CS
• Manufacturer Contact: kathy turner ; 3721 valley centre dr.; ste 500; san diego, CA 92130 ; 8587641240
• MDR Report Key: 4127731
• MDR Text Key: 4943410
• Report Number: 2939520-2014-00080
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 013350022081
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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