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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2018
Event Type  malfunction  
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 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 NameBREAST BIOPSY MARKER
Type of DeviceBREAST MARKER
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
sidra piracha
250 campus drive
marlborough, MA 01752
5082638884
MDR Report Key7608601
MDR Text Key111456905
Report Number1222780-2018-00134
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/20/2018
Device Catalogue NumberTRIMARK-EVIVA-2S-13
Device Lot Number605540
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2018
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

Patient Treatment Data
Date Received: 06/17/2018 Patient Sequence Number: 1
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