MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) MAESTRO 3000? CARDIAC ABLATION SYSTEM - CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M00421000TCR0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2014-02174.It was reported that a phrenic nerve damage occurred.A maestro 3000 cardiac ablation system pod and controller were selected for treatment.During procedure, a noisy fan was observed from the controller.Furthermore, it was noted that the pod had some loose components inside which caused a rattling sound.To ensure that the phrenic nerve was not in the area of ablation, the physician was pacing from a 4mm blazer ii htd ablation catheter.However, it was noted that an non-bsc stimulator was not pacing so the phrenic nerve was not captured thus the phrenic nerve was damaged causing breathing issues to the patient.The procedure was completed with another of the same device and the patient's breathing function has improved.

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: investigation completed.The device was returned to (b)(4) for evaluation.Device analysis noted that the fan was audibly noisy.However, it did not impact the functionality of the device and was not determined to have caused or contributed to the reported patient injury.The maestro controller passed power-on self-test, rf delivery tests, and all performance criteria of the final test procedure (without removal of the device's top enclosure).Environmental stress testing was also performed at high and low temperature and high and low line voltages with no problem found.The maestro controller also passed testing with maestro pod serial number (b)(4) involved in the same incident, with no errors reported and no problem found.During servicing of the maestro controller at (b)(4), the fan assembly was replaced with a new part due to obsolescence.The maestro controller in this complaint was manufactured prior to the fan assembly change.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id 2134265-2014-02174.It was reported that a phrenic nerve damage occurred.A maestro 3000 cardiac ablation system pod and controller were selected for treatment.During procedure, a noisy fan was observed from the controller.Furthermore, it was noted that the pod had some loose components inside which caused a rattling sound.To ensure that the phrenic nerve was not in the area of ablation, the physician was pacing from a 4mm blazer ii htd ablation catheter.However, it was noted that an non-bsc stimulator was not pacing so the phrenic nerve was not captured thus the phrenic nerve was damaged causing breathing issues to the patient.The procedure was completed with another of the same device and the patient's breathing function has improved.

• Brand Name: MAESTRO 3000? CARDIAC ABLATION SYSTEM - CONTROLLER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 1346 bordeaux drive; sunnyvale CA 94089
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3757702
• MDR Text Key: 15123708
• Report Number: 2134265-2014-02173
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2014

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: M00421000TCR0
• Device Catalogue Number: 21000TCR
• Device Lot Number: 100908023M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2014
• Initial Date FDA Received: 04/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2010
• 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
• Treatment: ST. JUDE EP MED STIMULATOR; BLAZER II ABLATION CATHETER
• Patient Outcome(s): Other