MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC LOCALIZER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number HB200-10

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 01/08/2021

Event Type  malfunction  

Event Description

Patient undergoing stereotactic guided tag localizer on left breast.When the tag was deployed, the provider said it felt unusual.When post-procedure imaging was done, the tag was several centimeters away from target.Provider could see tag was broken after deployment.Patient will need to return for another procedure due to defective product.Fda safety report id # (b)(4).

• Brand Name: HOLOGIC LOCALIZER
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.; marlborough MA 01752
• MDR Report Key: 11194688
• MDR Text Key: 227993240
• Report Number: MW5098866
• Device Sequence Number: 1
• Product Code: NEU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2021

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
• Device Operator: Health Professional
• Device Model Number: HB200-10
• Device Lot Number: 46517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 102