MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE 100; INSTRUMENT, BIOPSY

Model Number	ATEC SAPPHIRE 100
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
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.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.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) during an atec procedure the customer reported losing suction in the middle of an mri biopsy.The doctor could not continue with the biopsy.Customer was unsure if the patient will be rescheduled or not.Hologic did multiple attempts to obtain information no response.Customer reported that the suction was not functioning correctly and that the water was not being brought to the canister.No other information available.

• Brand Name: ATEC SAPPHIRE 100
• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 20675659
• Report Number: 1222780-2024-00425
• Device Sequence Number: 8304948
• Product Code: KNW
• UDI-Device Identifier: 15420045504028
• UDI-Public: (01)15420045504028(11)190520
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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
• Operator of Device: Health Professional
• Device Model Number: ATEC SAPPHIRE 100
• Device Catalogue Number: ATEC SAPPHIRE 100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown