MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC HYDROMARK BREAST BIOPSY SITE MARKER; BIOPSY SITE IDENTIFIER

Model Number	4010-05-10-T3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the event occurred after the procedure.The biopsy was preformed via mammotome revolve ultrasound.The hydromark clip was deployed through the probe.The biopsy and deployment all went good and nothing appeared to be wrong.When placing a hydromark clip marker in a biopsy case, the patient would not stop bleeding and had to be taken to surgery.Patient went into surgery and the marker was removed.
Additional Manufacturer Narrative
The hydromark 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 instruction for use and deployment guide, provided with the device, must be followed to avoid the applicator from shearing.In accordance with iso 13485:2016 and iso 10993-1 requirements, the hydromark ¿ biopsy site identifier devices have been tested for biocompatibility for their intended use and patient contact duration per iso 10993-1.The collagen marker and titanium clip are the only hydromark components classified as having permanent patient contact." components of the applicator are classified as "limited patient contact" and qualified for the intended use during the procedure.Applicator materials are considered medical-grade but have not been evaluated for permanent implantation.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.The event occurred after the procedure and the biopsy was preformed via mammotome revolve ultrasound.The hydromark clip was deployed through the probe.There were no issues during the biopsy and deployment of the marker.After the procedure was completed the patient was bleeding more than usual.Due to the additional bleeding the patient had the marker removed.When reviewing the images provided by the facility it was determined a failure of tip shear occurred.No further patient complications after the removal of the device.The marker was also disposed of after the removal.To date there has been no information to confirm permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage.After further investigation it was discovered that the device used in the procedure was expired.Per the instructions for use, the product must not be used beyond expiration date.
Additional Manufacturer Narrative
The initial report was submitted on 10-aug-2023.The purpose of this follow up report is to correct g6 in the initial report which should have also had the "initial" box checked.

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• 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 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 17500832
• Report Number: 3008492462-2023-00009
• Device Sequence Number: 6504580
• Product Code: NEU
• UDI-Device Identifier: 10841911102431
• UDI-Public: (01)10841911102431(17)230705(10)F12211107D
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 04/10/2024

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: 07/05/2023
• Device Model Number: 4010-05-10-T3
• Device Lot Number: F12211107D
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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 Age: 49 YR
• Patient Sex: Unknown