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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. BREAST BIOPSY MARKER; BREAST MARKER
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HOLOGIC, INC. BREAST BIOPSY MARKER; BREAST MARKER Back to Search Results
Catalog Number TRIMARK-EVIVA-2S-13
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is not being 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.(b)(4).
 
Event or Problem Description
It was reported the physician performed an eviva needle breast biopsy on (b)(6) 2018, and the single release system deployed two markers causing a potential risk for misdiagnosis.There was no patient injury.
 
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Brand Name
BREAST BIOPSY MARKER
Common Device Name
BREAST MARKER
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key7608601
Report Number1222780-2018-00134
Device Sequence Number11175694
Product Code NEU
UDI-Device Identifier15420045503588
UDI-Public(01)15420045503588(10)605540
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K023450
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source consumer,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date03/20/2018
Device Catalogue NumberTRIMARK-EVIVA-2S-13
Device Lot Number605540
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/13/2018
Initial Report FDA Received Date06/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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