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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK; BIOPSY SITE TISSUE MARKER DEVICE
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HOLOGIC, INC. TRIMARK; BIOPSY SITE TISSUE MARKER DEVICE Back to Search Results
Model Number TRIMARKTD-2S-36-09
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/09/2020
Event Type  Injury  
Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
 
Event Description
It was reported that at the end of an x-ray guided vab, the cannula of the biopsy marker site system was inserted, following the normal procedure.During the deployment of the marker clip, while pressing the plunger, as recommended, the user realized that the cannula of the device was shortened and the patient experienced pain.Mammographic views followed, which showed that a part from the marker clip, a broken part (17mm) of the distal end of the device was visualised within the breast, next to the clip.The device was removed and the user confirmed that there was a missing part of the cannula.Broken part of the cannula device remained within the breast and an unnecessary operation might be required to remove it.
 
Manufacturer Narrative
The reported device was returned to hologic for evaluation and the reported complaint was confirmed.Microscopic analysis concluded that the reported issue is attributed to the stress in the material of the bullet nose of the cannula.This observation will be monitored and trended.
 
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Brand Name
TRIMARK
Type of Device
BIOPSY SITE TISSUE MARKER DEVICE
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key10958495
MDR Text Key219956549
Report Number1222780-2020-00174
Device Sequence Number1
Product Code NEU
UDI-Device Identifier15420045503304
UDI-Public(01)15420045503304(10)19A07RM
Combination Product (y/n)N
PMA/PMN Number
K023450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/06/2021
Device Model NumberTRIMARKTD-2S-36-09
Device Catalogue NumberTRIMARKTD-2S-36-09
Device Lot Number19A07RM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Date Manufacturer Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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