MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK BIOPSY SITE MARKERS; BREAST BIOPSY MARKER

Model Number	TRIMARK-EVIVA
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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.Reference internal complaint (b)(4).
Event or Problem Description
It was reported the physician performed an eviva needle breast biopsy on (b)(6) 2017, and the single release system deployed two markers causing a potential risk for misdiagnosis.There was no patient injury.
Additional Manufacturer Narrative
We received 4 boxes qty=10 per box of eviva trimark-2s-13 new factory sealed biopsy site markers.The investigator along with an r+d representative randomly selected 3 new unused markers, all lot # 604583 from each of the 4 boxes of returned product.All 12 markers deployed a single marker only as designed.Complaint was not verified in product investigation lab.This observation will be monitored and trended.(b)(4).

• Brand Name: TRIMARK BIOPSY SITE MARKERS
• Common Device Name: BREAST BIOPSY MARKER
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 6980827
• Report Number: 1222780-2017-00262
• Device Sequence Number: 799854
• Product Code: NEU
• UDI-Device Identifier: 15420045503588
• UDI-Public: (01)15420045503588(10)604583
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K023450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/08/2018
• Device Model Number: TRIMARK-EVIVA
• Device Lot Number: 604583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1