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

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.

• Brand Name: BREAST BIOPSY MARKER
• Type of Device: BREAST 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: 7608601
• MDR Text Key: 111456905
• Report Number: 1222780-2018-00134
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 15420045503588
• UDI-Public: (01)15420045503588(10)605540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023450
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/20/2018
• Device Catalogue Number: TRIMARK-EVIVA-2S-13
• Device Lot Number: 605540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 06/17/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Other