MAUDE Adverse Event Report: STELLARTECH RESEARCH CORPORATION MAESTRO 4000¿ CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M00440000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that rf delivery did not stop.During a procedure, a maestro 4000 controller was used, however, radiofrequency delivery did not stop when the physician stopped pushing the footswitch.The procedure was completed with this device.No patient complications reported and the patient's condition is good.

Manufacturer Narrative

Device evaluated by mfr: the device was received for analysis.Examination of the returned device revealed that the foot switch was received back in over all good physical condition.Pedal presses down evenly with normal clicking sound.Connector and pins were found clean and aligned properly.Cable jacket in good physical shape.The foot switch was functionally tested by connecting an ohm meter between the hot pin and the outer return shield.The switch was activated and released several times.Each time it was activated the circuit closed and triggered the ohm meter.The cable was pulled and twisted in several ways to test for breaks in the internal wiring.None were found.The footswitch passed all testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that rf delivery did not stop.During a procedure, a maestro 4000¿ controller was used, however, radiofrequency delivery did not stop when the physician stopped pushing the footswitch.The procedure was completed with this device.No patient complications reported and the patient's condition is good.

• Brand Name: MAESTRO 4000¿ CONTROLLER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): STELLARTECH RESEARCH CORPORATION; 1346 bordeaux drive; sunnyvale CA 94089
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 1346 bordeaux drive; sunnyvale CA 94089
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5204372
• MDR Text Key: 30494629
• Report Number: 2134265-2015-07741
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00440000
• Device Catalogue Number: 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1