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

Model Number	4010-03-09-T3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
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 13485:2016and iso 10993-1 requirements, the hydromark ¿ biopsy site identifier devices have been tested for biocompatibility for their intended use and patient contactduration per iso 10993-1.The collagen marker and titanium clip are the only hydromark components classified as havingpermanent patient contact." components of the applicator are classified as "limited patient contact" and qualified for the intendeduse during the procedure.Applicator materials are considered medical-grade but have not been evaluated for permanentimplantation.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.It was reported by the affiliate that during procedure that the tip of the t3 clip introducer was in the biopsy bed.Images were taken and reviewed with the patient at the time of biopsy.After reaching out to the reporter it was determined the tip shear did go into the patients breast.The foreign material was immediately removed and the patient does not have to undergo an additional procedure.No further information has been provided by the customer.It has been made unclear by the reporter if the device is getting returned for investigation or if it was disposed of.
Event or Problem Description
It was reported by the affiliate that during procedure, a 39 year old patient underwent a needle biopsy of the leaft breast.In addition to the t3 clip, the tip of the clip introducer is also in the biopsy bed.Images were revied with the patient at the time of biopsy.Images were reviewed with the patient at the time of the biopsy.
Additional Manufacturer Narrative
The initial report was submitted on (b)(6) 2022.This follow up report is being submitted to correct grammar in b5 event details and d4 serial & lot number sections.The number was removed from serial number section and added to the lot number section.In addition, the initial report should have had the "initial" check box for g6.
Event or Problem Description
It was reported by the affiliate that during procedure, a 39 year old patient underwent a needle biopsy of the left breast.In addition to the t3 clip, the tip of the clip introducer is also in the biopsy bed.Images were reviewed with the patient at the time of biopsy.
Additional Manufacturer Narrative
The initial report was submitted 28-nov-2022.The purpose of this follow up report (#2) is to correct the following cells in the initial report: d4 'expiration date', 'unique identifier (udi)#' and d6b 'if explanted, give date' had "05-oct-2022" but should have been blank.

• 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: 15868956
• Report Number: 3008492462-2022-00014
• Device Sequence Number: 5218678
• Product Code: NEU
• UDI-Device Identifier: 00841911100140
• UDI-Public: (01)00841911100140(17)250504(10)F12219458D
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 06/05/2024

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: 05/04/2025
• Device Model Number: 4010-03-09-T3
• Device Lot Number: F12219458D
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 10/31/2022; Not provided
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 03/22/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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 Sex: Unknown