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

Model Number	TRIMARK TD-2S-36-09
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned a follow-up will be filed as needed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a biopsy procedure, "the clip did not come out during the procedure." no injury or misdiagnosis reported.A second device was used and a site marker was successfully placed.

• Brand Name: TRIMARK
• Common Device Name: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8545478
• Report Number: 1222780-2019-00093
• Device Sequence Number: 2458638
• Product Code: NEU
• UDI-Device Identifier: 15420045503359
• UDI-Public: 15420045503359
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K023450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: Health Professional
• Device Expiration Date: 06/25/2020
• Device Model Number: TRIMARK TD-2S-36-09
• Device Catalogue Number: TRIMARK TD-2S-36-09
• Device Lot Number: 18F26RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1