MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR BIOPSY SITE IDENTIFER (UNCONFIRMED); MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

A biopsy site identifier is a sterile, single-patient use device that is placed into soft tissue during a biopsy procedure to radiographically mark a surgical location.It is suspected that this adverse event is related to mammostar biopsy site identifiers but this could not be confirmed because no catalog number or lot identification information could be obtained.The procedure was completed, with three identifiers placed, with no reaction at that time.The patient reported a year later that all three sites developed some kind of tissue reaction "unconfirmed abscess." all three identifiers have been removed and two sites have fully resolved.The third identifier was removed three weeks ago and the recovery is ongoing.No additional information has been able to be obtained.The device was not returned for evaluation.Biocompatibility testing has been conducted and has determined that the device is non-irritating and non-sensitizing.The device history record was not reviewed because lot identification information could not be obtained.Appropriate controls are in place, however, for every lot manufactured to ensure that no discrepancies exist before release, including packaging and sterilization records.The information contained herein is being provided to fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or that a device is related to a death or injury.

Event Description

The patient reported that she had three biopsy site identifiers placed over one year ago.She reports experiencing some kind of tissue reaction "unconfirmed abscess." all three identifiers have been removed and two sites have fully resolved.The third identifier was removed three weeks ago and the recovery is ongoing.

• Brand Name: MAMMOSTAR BIOPSY SITE IDENTIFER (UNCONFIRMED)
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110 5876
• Manufacturer (Section G): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110 5876
• Manufacturer Contact: andrew adams ; 1290 hammond road; saint paul, MN 55110-5876 ; 6516538512
• MDR Report Key: 7074481
• MDR Text Key: 93446464
• Report Number: 2134494-2017-00001
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other