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

Model Number	MAM3008
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mammomark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.However, this failure mode is identified in the risk management file and will occur at the end of the procedure and involves the marker tip physically breaking.The failure mode involves the tip of a side deploy marker shearing on the cutter of a disposable probe and separating from the body of the marker.Should this failure mode occur, there is a chance the broken marker tip may be left in the patient's breast.Our current medical director reached out to the reporting physician to discuss the incident and stressed the importance of removal of the mammotome st device as delineated in ifu.The reporting physician was also provided a formal letter recommending the removal of the sheered materials.Based on the potential need of surgical intervention to remove the materials left behind we are submitting this medwatch report.
Event or Problem Description
During a procedure a marker was deployed into the patient but it did not show up in post images so they deployed a second marker.The second marker was successfully deployed but when the doctor tried to pull the product out from the breast there was resistance.After the procedure they could confirm that the distal tip of the applicator was still in the breast.The doctor is requesting information to see if the applicator tip needs to be removed.They are waiting on the results of the biopsy to see if the patient needs a lumpectomy and that they could remove the applicator tip at that time as well.
Additional Manufacturer Narrative
The mammomark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.However, this failure mode is identified in the risk management file and will occur at the end of the procedure and involves the marker tip physically breaking.The failure mode involves the tip of a side deploy marker shearing on the cutter of a disposable probe and separating from the body of the marker.Should this failure mode occur, there is a chance the broken marker tip may be left in the patient's breast.Our current medical director reached out to the reporting physician to discuss the incident and stressed the importance of removal of the mammotome st device as delineated in ifu.The reporting physician was also provided a formal letter recommending the removal of the sheered materials.Based on the potential need of surgical intervention to remove the materials left behind we are submitting this medwatch report.
Event or Problem Description
During a procedure a marker was deployed into the patient but it did not show up in post images so they deployed a second marker.The second marker was successfully deployed but when the doctor tried to pull the product out from the breast there was resistance.After the procedure they could confirm that the distal tip of the applicator was still in the breast.The doctor is requesting information to see if the applicator tip needs to be removed.They are waiting on the results of the biopsy to see if the patient needs a lumpectomy and that they could remove the applicator tip at that time as well.

• Brand Name: MAMMOMARK
• Common Device Name: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e business way; unit 500; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial,, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian rodriguez ; 300 e business way; unit 500; cincinnati, OH 45241
• MDR Report Key: 13197598
• Report Number: 3008492462-2021-00011
• Device Sequence Number: 5983948
• Product Code: NEU
• UDI-Device Identifier: 00841911101659
• UDI-Public: (01)00841911101659(17)230126(10)F12129369D
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 01/26/2023
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Device Lot Number: F12129369D
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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: Required Intervention
• Patient Sex: Female