MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE EP TECH EPT-1000XP? RF ABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M0041000XP0

Device Problems Device Emits Odor (1425); Smoking (1585); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

It was reported that noise, smoke and bad smell came out from the generator.An ep tech ept-1000xp rf ablation system was selected for an ablation procedure.During preparation, when the generator was turned on, the physician noticed noise, smoke and bad smell coming from the device.Furthermore, the display of the generator remained off.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status is stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.During visual inspection, a loose item was noted inside the device and were attributed to broken nylon standoff.There was no tamper proof seal on the unit.During investigation, the device failed to power on during initial power-on self-test (post).Following removal of the device's top enclosure, it was noted that the rf output harness which connects the rf board to the isom board was disconnected.After reconnecting the rf output harness, the device still failed post.Following replacement of the rf board with a known good board, the ept-1000 generator passed power-on self-test (post) and all performance criteria of the final test procedure.No other problems were found with the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is wear and tear.(b)(4).

Event Description

It was reported that noise, smoke and bad smell came out from the generator.An ep tech ept-1000xp¿ rf ablation system was selected for an ablation procedure.During preparation, when the generator was turned on, the physician noticed noise, smoke and bad smell coming from the device.Furthermore, the display of the generator remained off.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status is stable.

• Brand Name: EP TECH EPT-1000XP? RF ABLATION SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PLEXUS SERVICES CORPORATION; 2400 millbrook drive; buffalo grove IL 98011
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3792981
• MDR Text Key: 20979461
• Report Number: 2134265-2014-02719
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2009
• Device Model Number: M0041000XP0
• Device Catalogue Number: 1000XP
• Device Lot Number: 0000058700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/1998
• 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