MAUDE Adverse Event Report: HOLOGIC, INC SERTERA BIOPSY DEVICE; INSTRUMENT, BIOPSY

Model Number	SERTERA-14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.H3: the device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that on (b)(6), a sertera procedure was performed and when the radiologist fired the needle the first time outside the patient noticed the needle looked too long and fully fired so they decided to cocked it again to test it.This time the radiologist noticed the trough seemed to not be fully retracted in the needle when cocked.When the radiologist fired the needle came out and hit the wall and bounced off the wall and hit the floor.No additional information available.
Additional Manufacturer Narrative
Device evaluation: a visual inspection was conducted, and it was found that the inner cannula partially came out of the outer cannula.A functional test was not performed.Internal inspection was performed, and was found that the inner cannula hub was broken and the crimping due to the interaction between the inner and outer cannula was worn.Hence the complaint can be confirmed by disposable damage.

• Brand Name: SERTERA BIOPSY DEVICE
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102
• MDR Report Key: 19372201
• Report Number: 1222780-2024-00180
• Device Sequence Number: 7510214
• Product Code: KNW
• UDI-Device Identifier: 15420045504066
• UDI-Public: (01)15420045504066(17)260221(10)E24B22RC
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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: 02/21/2026
• Device Model Number: SERTERA-14
• Device Catalogue Number: SERTERA-14
• Device Lot Number: E24B22RC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female