MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME CORMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number MAM3014

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2018

Event Type  malfunction  

Event Description

Patient was undergoing ultrasound guided core needle biopsy in l breast.Radiologist deployed site identifier clip which felt different.Radiologist did not have to push as hard as normal to deploy it (less resistance).On post procedure mammogram, no clip was visualized.A second clip was immediately placed with no issues.Post mammogram showed successful deployment of second clip.No harm to patient.Incident delayed procedure by 10-15 minutes.Manufacturer response for biopsy site identifier, biopsy site identifier (per site reporter): manufacturer instructed to notify local representative.Facility will be credited for malfunctioning product.

• Brand Name: MAMMOTOME CORMARK
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e business way #5; cincinnati OH 45241
• MDR Report Key: 7315914
• MDR Text Key: 101611758
• Report Number: 7315914
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/14/2019
• Device Model Number: MAM3014
• Device Catalogue Number: MAM3014
• Device Lot Number: F11749456D
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR