MAUDE Adverse Event Report: COVIDIEN LLP (SHANGHAI) 30CM PERCUTANEOUS ANTENNA X1; ABLATION ANTENNA

Model Number	CA30L1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien reference#: (b)(4).Date of initial report: 02/17/2016.Evaluation of the incident antenna confirmed the reported event.Covidien¿s investigation identified two possible root causes for the device failure.The hub divider shifting distally within the hub or the inflow tube expanding or rupturing.Corrective actions have been implemented.A spacer was added to prevent the hub from shifting.Additionally, the inflow tube material was revised.The new inflow tube is made from polyimide, which results in inflow tubes with more strength reducing the likelihood of expansion or rupture.
Event or Problem Description
The customer reported that during a liver ablation procedure, the antenna was set up to the iv fluid bag and pump according to the instructions for use.The device was used successfully for the first ablation.The device was repositioned to ablate at another location.After operating for approximately 5 seconds the generator experienced a 'high temp alarm'.The nurse pressed the 'reset' button and the generator again displayed a 'high alarm'.After trying this 3 times, the nurse noticed that there was no dripping in the drip chamber.The tubing was inspected for kinks and none were found.The tubing was taken out of the pump and then put back into the pump.The nurse then hit the 'reset' button and again the generator displayed a 'high alarm'.The use of the system was discontinued.The procedure was not completed.There was no injury to the patient.

• Brand Name: 30CM PERCUTANEOUS ANTENNA X1
• Common Device Name: ABLATION ANTENNA
• Manufacturer (Section D): COVIDIEN LLP (SHANGHAI); 10 bldg, no.789 puxing rd; shanghai 20111 4; CH 201114
• MDR Report Key: 5442258
• Report Number: 3006451981-2016-00132
• Device Sequence Number: 13528555
• Product Code: NEY
• UDI-Device Identifier: 10884521189553
• UDI-Public: 01108845211895531717101310S5KG002X
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: CA30L1
• Device Catalogue Number: CA30L1
• Device Lot Number: S5KG002X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2016
• Initial Report FDA Received Date: 02/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR