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

Model Number M-5463-01

Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2015

Event Type  malfunction  

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.We are working on udi information, once we get more information it will be submitted in the supplemental.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow pump and stockert 70 system and there was a high flow rate activation problem.The stockert 70 system was displaying a low flow error when attempting to go on ablation.Later in the procedure, the coolflow pump was not spooling up to high flow when attempting to go on ablation.There was no error that populated.There was noise like when on ablation.However, the pump stayed at 2ml/min.The generator was set to auto mode.They confirmed that they had the correct catheter setting on the stockert 70 system.They were advised to disconnect and reconnect the cable connecting the stockert 70 system and coolflow pump.The issue then resolved.The procedure continued.There was no patient consequence.Since ablation is initiated and the irrigation pump does not change to high flow rate, this is a potential patient injury.Therefore, this issue has been assessed as reportable for the coolflow pump.Since the stockert 70 system was set to auto mode and the stockert 70 system did not populate an error during the high flow activation issue, this issue is also reportable under the stockert 70 system.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation, method - (actual device tested).Results, conclusion - (no malfunction found.Device is working properly).Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a coolflow pump and stockert 70 system and there was a high flow rate activation problem.The stockert 70 system was displaying a low flow error when attempting to go on ablation.Later in the procedure, the coolflow pump was not spooling up to high flow when attempting to go on ablation.There was no error that populated.There was noise like when on ablation.However, the pump stayed at 2ml/min.The generator was set to auto mode.They confirmed that they had the correct catheter setting on the stockert 70 system.They were advised to disconnect and reconnect the cable connecting the stockert 70 system and coolflow pump.The issue then resolved.The procedure continued.There was no patient consequence.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has not been verified.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5067829
• MDR Text Key: 26030341
• Report Number: 9612355-2015-00042
• 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: Followup
• Report Date: 08/12/2015

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 Model Number: M-5463-01
• Device Catalogue Number: S7001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1