MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTOME MR UNIVERSAL TARGETING SET; BIOPSY INSTRUMENT

Model Number MRU08X

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

The mammotome mr targeting set consists of a cradle, a sleeve mount assembly, and an obturator/stylet for accurate probe placement used to perform a breast tissue biopsy procedure.The device has not been returned for evaluation, which prevents a full investigation and analysis of the root cause at this time.X-ray image of the retained broken tip were provided and confirm the obturator proximal tip break.The instructions for use (ifu) state: insert obturator/stylet with depth markings into sleeve with z-lock; set and lock z-depth, aligning black triangle with top line of obturator/stylet; orient the cube; place cube in grid; insert targeting assembly into cube up to the z-lock.Caution: to minimize the risk of obturator breakage at the aperture, do not twist or torque the targeting set during insertion.Follow up with the radiologist at the user facility identified that he did not follow the ifu and placed the cube over the targeting set and attempted to insert the entire assembly into the grid.This can cause the targeting set to be inserted at an angle, unintentionally creating a fulcrum on the proximal end of the aperture.The patient underwent previously scheduled surgery to remove the breast lesion and obturator tip.No further complications reported.

Event Description

Devicor medical products, inc.Received a report from sales stating, legacy mr biopsy obturator broke off inside of patient's breast during mr biopsy.The patient was taken to previously scheduled surgery to have the biopsy and the tip of the obturator removed.This has been documented in our system as record # (b)(4).

• Brand Name: MAMMOTOME MR UNIVERSAL TARGETING SET
• Type of Device: BIOPSY INSTRUMENT
• 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 juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california
• Manufacturer Contact: jill burnett ; 300 e. business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 8344569
• MDR Text Key: 136303458
• Report Number: 3008492462-2019-00008
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00841911101093
• UDI-Public: (01)00841911101093(17)230712(10)F11827477D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042753
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: MRU08X
• Device Catalogue Number: MRU08X
• Device Lot Number: F11827477D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1