MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BREAST BIOPSY SITE MARKER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	4010-02-15-T4
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient undergoing ultrasound-guided core biopsy of a lesion.A biopsy marking clip was attempted to be deployed.It was reported that the clip was definitely not present on the sonographic images and no clip was present in the device after removal.The radiologist suspects the device did not contain a clip.The abnormality remains visible on mammography.The patient did not have any injury related to this event.Unfortunately, the device was not saved--only the wrapping that the device came in was saved.

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 15843059
• Report Number: 15843059
• Device Sequence Number: 5846106
• Product Code: NEU
• UDI-Device Identifier: 00841911102250
• UDI-Public: 00841911102250
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2022
• Report Date (Section F): 11/09/2022

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 Model Number: 4010-02-15-T4
• Device Catalogue Number: SKU CA000407005
• Device Lot Number: F12233448D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 11/09/2022