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

Model Number CA15L1

Device Problem Bent (1059)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/03/2015

Event Type  Injury  

Event Description

The customer reported that during a ct scan one month following an ablation procedure, a fragment of foreign material was detected in the ablated tissue.The fragment was not removed from the patient so the material was not identified.As no other devices were used in the ablation procedure, it is believed the fragment belongs to the antenna.During the original procedure, the antenna worked properly and no complications occurred.When the antenna was extracted from the patient it was noted to be bent but the unit was intact and no missing parts were noted.At that time the ct control confirmed a good result from the ablation.

Manufacturer Narrative

(b)(4).The incident antenna was discarded by the site and is not available for evaluation.Questions in regard to the incident have been asked.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

• Brand Name: 15CM PERCUTANEOUS ANTENNA X1
• Type of Device: MICROWAVE ABLATION ANTENNA
• Manufacturer (Section D): COVIDIEN LLC(SHANGHAI); 10 bldg, no.789 puxing rd; shanghai ; CH
• Manufacturer (Section G): COVIDIEN LLC (SHANGHA)I; 10 bldg, no.789 puxing rd; shanghai ; CH
• Manufacturer Contact: sharon murphy ; 5920 longbow dr; boulder, CO 80301 ; 2034925267
• MDR Report Key: 4711132
• MDR Text Key: 5736545
• Report Number: 3006451981-2015-00098
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Model Number: CA15L1
• Device Catalogue Number: CA15L1
• Device Lot Number: S4HG005X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 71 YR
• Patient Weight: 70