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

Model Number TRIMARK-EVIVA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2017

Event Type  Injury  

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 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.

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
• Type of Device: BREAST BIOPSY 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 Key: 6980827
• MDR Text Key: 91193974
• Report Number: 1222780-2017-00262
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 15420045503588
• UDI-Public: (01)15420045503588(10)604583
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K023450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1