MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 SYSTEM; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fistula (1862)

Event Date 11/11/2014

Event Type  Death  

Event Description

It was reported that after an atrial fibrillation procedure using a stockert 70 system generator on (b)(6) 2014, the patient expired on (b)(6) 2014 from an esophageal fistula.The esophageal fistula was confirmed during autopsy.During the procedure an esophageal probe was used along with carto sound contours of the esophagus.Based on the facts of the case and the physician¿s assessment, there were no reported malfunction with any of the catheters and systems used during the case.Thus, this event is unrelated to the device, and is related to the procedure.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).Concomitant products: c3 system sn: (b)(4), coolflow pump sn: (b)(4).Lasso catheter cat #: d134301, lot # unknown; soundstar catheter cat # sndstr10, lot #unk.Thermocool® smarttouch® bi-directional navigation catheter, lot#unk.(b)(4).Device has not been returned for analysis.

Manufacturer Narrative

Manufacturer's reference no: (b)(4).It was reported that after an atrial fibrillation procedure using a stockert 70 system generator on (b)(4) 2014.The patient expired on (b)(6) 2014 from an esophageal fistula.Repair follow-up was performed, however, the customer declined service.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT 70 SYSTEM
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4372041
• MDR Text Key: 17291774
• Report Number: 9612355-2014-00064
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2014

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 Model Number: M-5463-01
• Device Catalogue Number: S7001
• Other Device ID Number: (1)4260166370195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death