MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number 39D-76X

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the displayed temperature of the smart touch catheter was 53 degree celsius.The ablation could be conducted at 53 degree celsius although the cut-off was set to 44 degree celsius.As the physician noticed the issue, he stopped the ablation.After that, the temperature cut-off function was activated properly spontaneously as the temperature did not soar until 44 degree celsius.The procedure was completed with using the catheter.The procedure was completed without patient consequence.Per the event description stating, "the ablation could be conducted at 53 degrees celsius although the cut-off was set to 44 degree celsius" is indicative of a reportable event.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.Concomitant product: smart touch bidirectional, mfg #: d-1327-05-s, lot #: 16040760m.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during an atrial fibrillation (afib) procedure, the displayed temperature of the smart touch catheter was 53 degree celsius.The ablation could be conducted at 53 degree celsius although the cut-off was set to 44 degree celsius.As the physician noticed the issue, he stopped the ablation.After that, the temperature cut-off function was activated properly spontaneously as the temperature did not soar until 44 degree celsius.The procedure was completed with using the catheter.The procedure was completed without patient consequence.The device was evaluated and the issue was not reproducible.The system was replaced for prevention purposes.Replacement of the module 331 was for preventive purposes.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 EP-SHUTTLE RADIO FREQUENCY 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3761232
• MDR Text Key: 4549041
• Report Number: 9612355-2014-00021
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

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: 39D-76X
• Device Catalogue Number: 39D-76X
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1