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

Model Number M-5463-01

Device Problem Insufficient Information (3190)

Patient Problems Air Embolism (1697); Atrial Fibrillation (1729); Stroke/CVA (1770); Infarction, Cerebral (1771); Death (1802); Fistula (1862); Weakness (2145)

Event Date 12/21/2015

Event Type  Death  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Since the serial number is unknown, the full udi number cannot be provided.(b)(4) are related to the same incident.

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for persistent atrial fibrillation with a thermocool smarttouch bi-directional navigation catheter and stockert 70 rf generator and suffered esophageal fistula, cerebrovascular accident, and death.On (b)(6) 2015, ablation was performed which consisted of pulmonary vein isolation and left atrial roof line.Smarttouch ablation catheter used with stockert 70 generator.Esophageal temperature monitoring showed no rise above 37°c.On (b)(6) 2015, patient presented to emergency room with sudden-onset left-sided weakness affecting the arm and leg.Patient admitted for signs and symptoms of stroke.Symptoms worsened over time.Patient diagnosed with multifocal cerebral embolic infarcts secondary to air emboli from esophageal atrial fistula.Patientfamily decided to withdraw care and to place patient in hospice care.On (b)(6) 2015, patient expired.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on november 7, 2016.The serial# (b)(4) was provided.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).(b)(4).It was reported that a (b)(6) female patient underwent an ablation procedure for persistent atrial fibrillation with a thermocool smarttouch bi-directional navigation catheter and stockert 70 rf generator and suffered esophageal fistula, cerebrovascular accident, and death.Repair follow-up was performed and device was not shipped for service.Service was declined.Complaint was unable to be confirmed.The device history record review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT 70 RF GENERATOR
• 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-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5451488
• MDR Text Key: 38705274
• Report Number: 9612355-2016-00012
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

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 Model Number: M-5463-01
• Device Catalogue Number: S7001
• Other Device ID Number: SEE H10.
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR