MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP II TISSUE MARKER; BIOPSY INSTRUMENT

Model Number	861217
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (04/2022).
Event or Problem Description
It was reported that one week after placement of a breast tissue marker, the patient is experiencing severe pain.The markers are not scheduled to be removed at this moment.
Event or Problem Description
It was reported that one week after placement of a breast tissue marker, the patient is experiencing severe pain and redness.The marker is not scheduled to be removed at this moment.
Additional Manufacturer Narrative
Manufacturing review: the dhr has been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.No images or medical records were provided for review.Therefore, the investigation is inconclusive for patient-device incompatibility as no objective evidence was provided to confirm a deficiency with the device.The definitive root cause could not be determined based upon available information.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.Expiry date (04/2022).

• Brand Name: ULTRACLIP II TISSUE MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8947306
• Report Number: 2020394-2019-03036
• Device Sequence Number: 19357737
• Product Code: GDW
• UDI-Device Identifier: 00801741032271
• UDI-Public: (01)00801741032271
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K993785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 861217
• Device Catalogue Number: 861217
• Device Lot Number: HUDS1775
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR