MAUDE Adverse Event Report: COVIDIEN LP BARRX BEACON; KIT, NEEDLE, BIOPSY

Model Number F-22-05

Device Problem Insufficient Information (3190)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the endoscopic ultrasound-guided fiducial placement, the physician tried to verify the fiducial placement using endoscopic ultrasound and x-ray, but fiducials were not visible.They used another needle to complete the procedure.The needle will be returned for investigation.The patient was prepped for the procedure and was under anesthesia, no repeat procedure was necessary, and there was no user harm.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The customer reported the fiducials could not be located.The visual inspection found no damage to the device and no fiducials were in the device at the time of this inspection.No other notable conditions were noticed.The investigation could not determine the root cause of the event.The reported condition was not confirmed.No corrective action is required.Trending is performed per local procedure.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BEACON
• Type of Device: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 8331159
• MDR Text Key: 135873789
• Report Number: 3004904811-2019-00005
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: F-22-05
• Device Catalogue Number: F-22-05
• Device Lot Number: B000000657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention