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

Model Number CA15L1

Device Problem Energy Output Problem (1431)

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

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: 02/05/2016.This complaint is part of a retrospective review as part of a remediation related to capa (b)(4).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 Description

The customer reported the antenna was going to be used for two separate ablations in same patient in different liver locations.They performed the first ablation as intended with no issues.The antenna was completely removed and reinserted into the 2nd lesion.The emprint generator was set for 8 min 30 sec at 75w.The energy was activated and a temperature alert caused the energy to be discontinued.It was discovered the saline pump had been turned off resulting in the hi temp alert.The pump was then turned on and the generator reset for the desired settings.After approx.25 seconds another temperature alert caused the energy to be discontinued.Upon further inspection it was noticed the saline flow was decreased to a drip.A second antenna was then opened and placed in the desired liver location.The ablation with the 2nd antenna performed as expected with no further issues.The procedure completed with no evidence of abnormal out come and no patient injury.

• Brand Name: 15CM PERCUTANEOUS ANTENNA X1
• Type of Device: ABLATION ANTENNA
• 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: 5414050
• MDR Text Key: 38126271
• Report Number: 3006451981-2016-00118
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: 10884521189539
• UDI-Public: 01108845211895391717061010S5FG004X
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S5FG004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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