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

Model Number 4010-02-15-T4

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  malfunction  

Event 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
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 15843059
• MDR Text Key: 304124101
• Report Number: 15843059
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00841911102250
• UDI-Public: 00841911102250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022,11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33580 DA
• Patient Sex: Female
• Patient Weight: 54 KG