MAUDE Adverse Event Report: COVIDIEN LLC (SHANGHAI) 15CM PERCUTANEOUS ANTENNA X1; ABLATION ACCESSORY

Model Number CA15L1

Device Problems Difficult to Insert (1316); Dull, Blunt (2407)

Patient Problem Blood Loss (2597)

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Event Description

The customer reported that the radiologist tried to insert the antenna into the kidney tumor but he did not succeed because the antennas tip was not sharp enough.He tried to insert the antenna four times with no success.Another type of device was used for the procedure.However, there was a delay in the procedure of over 30 minutes.Additionally, a blood loss of approximately 500 ml was created by the failed attempts to insert the antenna.No further information was provided.(b)(4).

Manufacturer Narrative

(b)(4).Date of initial report: 11/11/2015.Date of follow-up report: 01/28/2016.Evaluation of the incident antenna did not confirm the customer's report.The antenna was found to be sharp.The antenna functioned properly and within specifications.No conditions were identified that would have caused or contributed to the reported event.

• Brand Name: 15CM 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: 5217912
• MDR Text Key: 30987711
• Report Number: 3006451981-2015-00277
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S4JG004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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 Outcome(s): Other