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U.S. Department of Health and Human Services

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

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HEALTH BEACONS, INC. LOCALIZER TAG APPLICATOR Back to Search Results
Model Number HB200-10
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/22/2021
Event Type  malfunction  
Event Description
On 25-jan-2021 health beacons found out about a case at anmed health in (b)(6), where the user stated that the localizer tag was deployed and that it was broken inside the patient's breast. Images were provided for investigation, and it was concluded that the tag was broken. On 27-jan-2021, health beacons investigator had a preliminary discussion with the hologic clinical specialist, regarding the implant procedure. It was learned that this facility has been implanting tags for about a year. The radiologist said that they felt a "resistance" during insertion and then noted from the images that the tag was broken. (orthogonal images attached) no additional details about that resistance or breakage were provided. It was determined that no medical intervention was required. It is concluded that the ifu warning was not followed, which indicates that if resistance is encountered, the needle should be repositioned, and the user should never apply strong forces in order to overcome the obstacle. On (b)(6) 2021, the surgery to remove the lesion and tag was performed as scheduled. The surgeon that conducted the explant of the tag reported that he could locate the tag and clip "by feel", since the rfid tag was non-funcional. Follow-up communications confirmed that the explant was successful and the tag was fully removed from the breast.
 
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Brand NameLOCALIZER
Type of DeviceTAG APPLICATOR
Manufacturer (Section D)
HEALTH BEACONS, INC.
250 campus drive
marlborough MA 01752
Manufacturer (Section G)
RANFAC CORPORATION
30 doherty avenue
avon MA 02322
Manufacturer Contact
sumanesh agrawal
250 campus drive
marlborough, MA 01752
5203998155
MDR Report Key11364820
MDR Text Key259988069
Report Number3013649990-2021-00002
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHB200-10
Device Lot Number46517
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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