MAUDE Adverse Event Report: HEALTH BEACONS, INC. LOCALIZER; TAG APPLICATOR S

Model Number HB300-05

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/28/2020

Event Type  malfunction  

Event Description

On 01-jun-2020 health beacons received complaint (b)(4).The complaint indicated that the localizer capsule (sheath) was missing from the tag when it was removed from patient.The tag was exposed during surgery and placed on back table.The representative indicated that the surgeon thought she may have touched the tag with the electrocautery device.Several requests for additional information to facilitate the investigation of the complaint have been submitted as follows: week of 01-jun-2020 - text was sent to representative, indicating that we needed additional information to investigate issue.- no response.09-jun-2020 - emailed indicating that the complaint would be handled as a reportable event, and asking if the sheath was discovered during pathology of the resected tissue, or if an ultrasound was conducted on the patient to look for any trace of the sheath in the breast.Response: representative indicated that they did not have the information but would ask the physician on 12-jun-2020.12-jun-2020 - follow up email was sent asking if the physician had been able to provide additional information.- no response.17-jun-2020 - follow up email was sent requesting information.Response: on 19-jun-2020 representative sent a text to the physician requesting information.30-jun-2020: representative visited the hospital to follow up in person as the surgeon has not responded to voicemails and texts.As it has been difficult to obtain information from the hospital because of personnel restrictions due to covid-19, we have not been able to fully understand the event, but out of an abundance of caution, we are reporting this incident as a device malfunction.The sheath may have melted fully or partially from the tag, leaving it unrecognizable but still in the tissue; it may have separated but remained in the excised tissue or it may have separated and remained in the breast (this is the least likely scenario, because it would mean it also migrated).Even in the event the sheath remains in the patient's breast, it is not being considered a serious injury, as the device is approved as a permanent implant.If additional information about the incident is obtained, a follow-up report will be submitted.

• Brand Name: LOCALIZER
• Type of Device: TAG APPLICATOR S
• Manufacturer (Section D): HEALTH BEACONS, INC.; 250 campus drive; marlborough, ma
• Manufacturer (Section G): RANFAC CORPORATION; 30 doherty avenue; avon, ma
• Manufacturer Contact: dhaval saraiya ; 250 campus drive; marlborough, ma ; 3034835
• MDR Report Key: 10228606
• MDR Text Key: 232760260
• Report Number: 3013649990-2020-00002
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: HB300-05
• Device Lot Number: 43084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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