MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS BREAST LOCALIZATION WIRE; BIOPSY INSTRUMENT

Model Number	475201
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The photo review is currently underway review.
Event or Problem Description
It was reported that post placement of a localization wire, an artifact allegedly was found on mri imaging.Reportedly, the patient went to the or to remove the localization wire.It was further reported that there was no any additional intervention was required.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: complaint history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: five sealed ghiatas lot samples were returned for evaluation and one mr image was provided for review.The returned samples could not be functionally evaluated as the conditions of use could not be replicated (i.E.Mr imaging with parameters used during procedure).Per the image review performed by healthcare provider, an artifact was identified in the mr image provided.As such, the investigation is confirmed for the reported artifact.Per the ghiatas instructions for use, "non-clinical testing has demonstrated that the mr ghiatas® localization wire is mr conditional.It can be scanned safely under the following conditions: static magnetic field of 3-tesla or less spatial gradient field of 720-gauss/cm or less in non-clinical testing, the mr ghiatas® localization wire product codes produced a temperature rise of less than +0.9°c at a maximum mr system reported whole body averaged specific body absorption rate (sar) of 3-w/kg of 15-minutes of mr scanning in a 3-tesla, signa mr system (excite platform; g3.0-052b software, ge healthcare, milwaukee, wi).Mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the mr ghiatas® localization wire.Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant." as such, it is possible that imaging parameters contributed to the reported artifact.However, the definitive root cause could not be determined based upon available information.Per the image review, it is also possible that the implanted biopsy clip contributed to the reported artifact.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that post placement of a localization wire, an artifact allegedly was found on mri imaging.Reportedly, the patient went to the operating room to remove the localization wire.It was further reported that there was no any additional intervention was required.The current patient status is unknown.

• Brand Name: GHIATAS BREAST LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8842928
• Report Number: 2020394-2019-02020
• Device Sequence Number: 19234113
• Product Code: GDF
• UDI-Device Identifier: 00801741079917
• UDI-Public: (01)00801741079917
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: E149699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 475201
• Device Catalogue Number: 475201
• Device Lot Number: REDR2967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 03/12/2020
• 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: Hospitalization
• Patient Age: 48 YR
• Patient Weight: 68