MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK; BIOPSY SITE TISSUE MARKER DEVICE

Model Number TRIMARK-EVIVA-13

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been 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.

Event Description

It was reported that after deploying the biopsy site identifier, post biopsy mammography images were obtained.The radiologist noted what appears to be a metallic foreign body in the images that does not correlate to the site marker and was not seen on post biopsy imaging.The reported device has been requested to return to hologic for evaluation.

Manufacturer Narrative

The reported biopsy marker was received by hologic for evaluation.A visual inspection of the device noted no missing or damaged component.The aperture indicator was oriented in the correct way and the plunger was latched to the aperture indicator.The spring was correctly seated on the pushrod end.The reported issue could not be confirmed since the device did not show any broken or missing part.

• Brand Name: TRIMARK
• Type of Device: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11628666
• MDR Text Key: 247208868
• Report Number: 1222780-2021-00071
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 15420045503571
• UDI-Public: 15420045503571
• Combination Product (y/n): N
• PMA/PMN Number: K023450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: TRIMARK-EVIVA-13
• Device Catalogue Number: TRIMARK-EVIVA-13
• Device Lot Number: 20M08RJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1