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

Model Number SMARK-EVIVA-13

Device Problem Failure to Eject (4010)

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

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Internal reference #: (b)(4).

Event Description

It was reported that during the procedure the marker failed to deploy three times.All markers that failed were from the same lot.The procedure length was extended and therefore the patient remained under compression for longer than necessary.Biopsy was completed with no marker placed.No additional details available.

• Brand Name: SECURMARK
• Type of Device: BIOPSY SITE TISSUE MARKER DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 8933002
• MDR Text Key: 155628928
• Report Number: 1222780-2019-00198
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 15420045503618
• UDI-Public: (01)15420045503618(10)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: SMARK-EVIVA-13
• Device Catalogue Number: SMARK-EVIVA-13
• Device Lot Number: 19A08RD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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