MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOMARK CLIP

Model Number MAMMOMARK 2-11

Device Problems Material Fragmentation (1261); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

Stereotactic breast biopsy was attempted using mammomark.Catheter containing mammomark clip was placed into mammotome device, however, plunger was met with resistance and catheter was removed.A new clip catheter was advanced and placed in proper position.Mammogram later showed segment of clip catheter retained in breast at biopsy site.Pt undecided on having surgical procedure to remove object at this time.

• Brand Name: MAMMOMARK CLIP
• Type of Device: CLIP
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; cincinnati OH 45241
• MDR Report Key: 3820333
• MDR Text Key: 20717859
• Report Number: MW5036135
• Device Sequence Number: 2
• Product Code: NEU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: MAMMOMARK 2-11
• Device Catalogue Number: MAM3002
• Device Lot Number: F11409402D1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 88