MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MEH1 MAMMOTOME ELITE HOLSTER; BIOPSY DEVICE

Model Number MEH1

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Vessels (2135)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

The mammotome elite biopsy system is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.A breast biopsy procedure using a mammotome elite holster (meh1) with a mammotome elite probe was conducted on april 28, 2017, during which a vessel was hit causing increased bleeding.The possibility of bleeding exists with any biopsy procedure and some biopsies will have it more than others, based on the anatomy of the patient and the lesion.Bleeding complications are almost always limited to bleeding that can be stopped with manual pressure (5-10 minutes common).In some cases, it is not possible to avoid the vessel, as the vessel is too close to the target lesion.Additionally, some tumors create neo-vascularity, where the tumor creates a network of blood vessels to feed the tumor.This can contribute to a higher potential of bleeding at the biopsy site.One meh1 was received and investigated on may 19, 2017.The device was found to have excessive fluid ingress.The probe utilized within the procedure was not returned and could not be investigated.An additional meh1 device was tested using simulated blood material and colored water to try and recreate the voice of the customer.In normal usage, the failure mode was unable to be created, as a hydrophobic filter is placed in every disposable probe to prevent contamination between the probe and the holster.The investigation team intentionally damaged the probe under test, after which the failure mode was able to be recreated.The potential root cause is a damaged device.No additional confirmation was possible as the disposable probe used in the procedure was not returned for investigation.The probe manufacturing facility performs a 100% device leak test, 100% device torque test and 100% device filter occlusion test to ensure that the disposable probes meet the intended use and that every probe has a hydrophobic filter in place to prevent this occurrence.The device history record was reviewed and the device was determined to be conforming.Follow up with the sales rep indicated that the fluid exited the device between the probe and sample collection cup and did not eject out of the back of the holster as originally reported.Pressure was applied to the patient and no further intervention was necessary.However, as teh occurrence has to potential to result in patient consequence with the need to forgucal intervention or other form of treatment, and pursuant to 21 cfr803, we are submitting this medwatch report.

Event Description

It was reported by the sales manager that during a procedure the customer reported meh1 had fluid ingress.A vessel was hit during a procedure and blood ejected from the back of the holster.The procedure was completed with another device.No patient complications.

• Brand Name: MEH1 MAMMOTOME ELITE HOLSTER
• Type of Device: BIOPSY DEVICE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): NORTECH SYSTEMS, INC.; 925 sixth avenue ne; milaca ME 56353
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 6595081
• MDR Text Key: 76091978
• Report Number: 3008492462-2017-00035
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEH1
• Device Catalogue Number: MEH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other