MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOMARK; BIOPSY SITE IDENTIFIER

Model Number	MMK1001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the doctor reported a tip shear during biopsy procedure.After post films were taken, it was confirmed that only the marker was in the breast and no other fragments.The doctor confirmed the tip of the marker applicator was stuck in the probe needle.The issue occurred after the procedure.The procedure was successfully completed with this device.Marker is in the breast but migrated a little per radiologist.No patient complications were reported.
Additional Manufacturer Narrative
The mammomark biopsy site identifiers are composed of a bioresorbable collagen plug embedded with a non-resorbable permanent radiopaque titanium wire marker.Each mammomark site identifier is packaged sterile in a flexible, disposable applicator for single patient use.The packaging also includes a sterile marker sheath at the distal end of the applicator shaft designed to retain the marker within the applicator shaft prior to use with mammotome revolve biopsy probes.According to the reporter, the doctor reported a tip shear during biopsy procedure.After post films were taken, it was confirmed that only the marker was in the breast and no other fragments.The doctor confirmed the tip of the marker applicator was stuck in the probe needle.The issue occurred after the procedure.The procedure was successfully completed with this device.Marker is in the breast but migrated a little per radiologist.No patient complications were reported.The device was not returned for evaluation.The radiopaque tip of the mammomark applicator shaft may shear when the marker applicator is rotated or removed independently from the probe.The probability of a tip shear can increase as a result of the following: improper deployment of the collagen plug from a failure to align the mammomark applicator as specified.Inserting beyond the appropriate color depth indicator band.Failure to advance plunger completely during deployment.Failure to ensure the cutter is fully retracted before placing the marker through the probe.Applicator not inserted fully.Diagnostic tissue remaining in biopsy probe needle aperture during marker insertion and deployment.This failure mode and the resultant harm is a predicted misuse.The current procedural occurrence confirms that this has been reduced as far as possible.Although no patient/user injury occurred, we are reporting this event as this failure mode has been reported in the past.
Additional Manufacturer Narrative
The initial report was submitted 15-may-2024.The purpose of this follow up report is to include the missing d4 catalog number and correct g1 contact office - manufacturing site (state abbreviation).

• Brand Name: MAMMOMARK
• Common Device Name: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b, parque industrial; tijuana, mex 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; sor juanaines de la cruz; #20152 4-b, parque industrial; tijuana, bc, OH 22440 ; MX 22440 ; 5138649047
• MDR Report Key: 19324093
• Report Number: 3008492462-2024-00006
• Device Sequence Number: 6520075
• Product Code: NEU
• UDI-Device Identifier: 00841911101611
• UDI-Public: (01)00841911101611(17)241028(10)F12317464D
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2024
• Device Model Number: MMK1001
• Device Catalogue Number: MMK1001
• Device Lot Number: F12317464D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown