MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM RF GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M-4900-07

Device Problems Break (1069); Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2017

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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that during testing of a smartablate¿ system rf generator foot pedal, damage was discovered.The foot pedal had a broken cover and the pedal sticks when depressing and did not release.No procedure was being performed.This event is mdr reportable because, if this was during a procedure, this issue can cause unwanted ablation which can lead to issues such as perforation, cardiac tamponade, or arrhythmia.

Manufacturer Narrative

(b)(4).It was reported that during testing of a smartablate¿ system rf generator foot pedal, damage was discovered.The foot pedal had a broken cover and the pedal sticks when depressing and did not release.Repair follow-up was performed and there was no response from the customer.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: SMARTABLATE¿ SYSTEM RF GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6306190
• MDR Text Key: 67208637
• Report Number: 9612355-2017-00006
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 4260166371390
• UDI-Public: (01)4260166371390(11)150623
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S017
• 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: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4900-07
• Device Catalogue Number: M490007
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1