MAUDE Adverse Event Report: COOK INC X-REIDY BREAST LESION LOCALIZATION NEEDLE; MIJ NEEDLE, TUMOR LOCALIZATION

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: unknown.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a female patient required the placement of an x-reidy breast lesion localization needle.The operator reported when removing the wire from the needle, "the needle felt gritty." upon complete withdrawal of the needle, post guidewire images were obtained demonstrating an approximate 4mm fragment of wire had been left in the breast tissue.The operator used a competitors wire to complete the localization of the breast tissue successfully.It was reported that the fragment of wire in the breast tissue was recovered during a planned surgery to remove cancer from that breast.No other adverse effects were reported for this incident.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Since relevant dimensions could not be measured against specification, the device cannot be confirmed to be measured against specification.However, a document based investigation evaluation was performed.Sufficient controls are in place to detect this failure mode prior to release.The risks of this device are acceptable when weighed against the benefits.A review of the device history record (dhr) showed no related nonconformances.A database search revealed no other complaints under this lot number at the time of this investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.The device is shipped with instruction for use (ifu) which notes: warnings: "under no circumstances should a hook wire engaged in tissue be pulled out without surgical intervention." precautions: "x-reidy breast lesion localization needle sets are intended for use by physicians trained and experienced in breast lesion localization techniques.Standard techniques for placement of hook wires should be employed." how supplied: "upon removal of package, inspect the product to ensure no damage has occurred." the customer reported difficult advancement.Tortuous patient anatomy may have contributed to this since a malignant lesion is likely to be harder to penetrate than normal breast tissue.The ifu states, ¿under no circumstances should a hook wire engaged in tissue be pulled out without surgical intervention.¿ it is unclear whether or not the hookwire was attempted to be withdrawn after some difficulty was felt during its advancement.Similarly, it cannot be determined whether the fragment in the provided imaging belonged to a proximal or distal leg of the hookwire.Thus use error cannot be confirmed.Based on the information provided, the examination of returned product and the results of the investigation, has concluded that either patient condition or unintended use error may have contributed to the event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: X-REIDY BREAST LESION LOCALIZATION NEEDLE
• Common Device Name: MIJ NEEDLE, TUMOR LOCALIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9371591
• Report Number: 1820334-2019-02950
• Device Sequence Number: 2489950
• Product Code: MIJ
• UDI-Device Identifier: 00827002195332
• UDI-Public: (01)00827002195332(17)240415(10)9668779
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: N/A
• Device Catalogue Number: DXRBL-19.5-9.0-S
• Device Lot Number: 9668779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other