MAUDE Adverse Event Report: VOLCANO CORPORATION SYNC-RX SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number TLA, SYNCVISION

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This case is under investigation dbr according to the manufacturer's policy.There was no patient involvement and therefor no patient information is available.A review of complaint cases submitted for this asset was performed and no other similar complaints were reported on this asset for this failure.This complaint will be monitored as part of complaint data analysis.

Event Description

The facility reported to the manufacturer that a joystick installed on the system had intermittent functionality.A replacement kit of local usb extender and remote usb extender (lex/rex) was sent to the facility.The facility engineer reported that after connecting the rex extender to the usb cat5 cable they immediately smelled what appeared to be burnt electrical.The failed lex/rex kit was returned to the manufacturer for analysis.The returned lex/rex kit was investigated according to the manufacturer's policy.The reported burned smell and burn damage was confirmed on the rex pcb.The reported incident did not occur during a patient procedure, there was no patient involvement.

• Brand Name: SYNC-RX SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): VOLCANO CORPORATION; 1 fortune dr; bellerica MA 01821
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 5909071
• MDR Text Key: 53278708
• Report Number: 2939520-2016-00062
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TLA, SYNCVISION
• Device Catalogue Number: 400-0100.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1