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

Model Number CA30L1

Device Problems Difficult to Insert (1316); Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation of the incident antenna found it to function normally and within specifications.No conditions were identified that would have caused or contributed to the reported event.

Event Description

The customer reported that the doctor indicated that the location of the tumor and access to it involved him crossing over segments 4 and 5 and that it was a difficult insertion.To reach the lesion at least 4 attempts were made to steer the antenna towards the lesion.If proper placement was unsuccessful, the doctor would withdraw the antenna and, at the same time ablate the tract.The depth of insertion was around 12 cm on each attempt.The doctor was successful in placing the antenna.During the procedure, the generator indicated an alert with alarm described as antenna temperature limit exceeded and the microwave power was automatically disabled.Saline flow to the antenna was verified.The pump operation and proper set up were verified.The temperature of the fluid in the iv bag was normal.The reset button was pressed and the ablation start/stop button on the generator was pushed.Immediately, the generator disabled the delivery of microwave power and the antenna temperature limit exceeded icon was illuminated.This process was repeated again with the same result.The use of the emprint system was discontinued and the procedure was not completed.There was no injury to the patient.(b)(4).

Manufacturer Narrative

(b)(4).Date of follow-up report: 11/4/2015.

Event Description

Additional information provided by the customer: the patient was (b)(6) years old and weight (b)(6).The procedure was delayed by more than 30 minutes.Minor bleeding occurred.

• Brand Name: 30CM PERCUTANEOUS ANTENNA X1
• Type of Device: ABLATION ACCESSORY
• Manufacturer (Section D): COVIDIEN LLC (SHANGHAI); 10 bldg, no.789 puxing rd; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN LLC (SHANGHAI); 10 bldg, no.789 puxing rd; shanghai 20111 4; CH 201114
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5181901
• MDR Text Key: 29974560
• Report Number: 3006451981-2015-00255
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: CA30L1
• Device Catalogue Number: CA30L1
• Device Lot Number: S4LG004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 80