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

Model Number	ILS 0914-20
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2023
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.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.2 devices were involved in this event: 1222780-2024-00022.
Event or Problem Description
It was reported that during an mri biopsy on (b)(6) 2023, during the biopsy the introducer localization trocar system cap detached inside the patient, the defective equipment was removed, and a second localization system was opened.The same issue happened again but the radiologist held the piece in place and continued with the biopsy.Unknown to the radiologist that a malleable piece had been lodged into the trocar casing when the radiologist advanced the trocar into the patient it lodged the malleable defective piece into the patient's left breast.It was discovered when the patient went for a post-mammogram clip placement.No additional information available.

• Brand Name: ATEC INTRODUCER
• 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 20102 ; CR 20102
• MDR Report Key: 18542248
• Report Number: 1222780-2024-00021
• Device Sequence Number: 18087560
• Product Code: KNW
• UDI-Device Identifier: 15420045503205
• UDI-Public: (01)15420045503205(17)250207(10)E23B08RG
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2024

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 Expiration Date: 02/07/2025
• Device Model Number: ILS 0914-20
• Device Catalogue Number: ILS 0914-20
• Device Lot Number: E23B08RG
• 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: 12/28/2023
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female