MAUDE Adverse Event Report: BD PERIPHERAL INTERVENTION ULTRACLIP II MARKER; BIOPSY INSTRUMENT

Model Number	864017
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is being reported as a reportable malfunction for the special cause related to these product catalog/lot number combinations which is the subject of report of corrections and removal letter (806 notification) on may 2, 2019.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, however an image was provided for review.The investigation is currently underway.Expiry date (09/2021).
Event or Problem Description
It was reported that after placement of the device, it allegedly created a significant artifact under mri.It was further reported that this artifact allegedly hid the enhancement from a small, previously placed, cancer clip.The current patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: per the complaint history report, this is the first complaint reported for this lot number.A dhr is not required for the first complaint in a lot.Based upon the severity level and lot quantity, the number of events is at or below the acceptable quality levels.Investigation summary: no sample was returned for review, however, one electronic image was received and reviewed by dr.(b)(6) on (b)(6) 2019.It was noted that the marker from image 2 was larger than expected.Therefore, the investigation is confirmed for the alleged signal artifact.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.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 after placement of the device, it allegedly created a significant artifact under mri.It was further reported that this artifact allegedly hid the enhancement from a small, previously placed, cancer clip.The current patient status is unknown.

• Brand Name: ULTRACLIP II MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BD PERIPHERAL INTERVENTION; 1415 w. 3rd street; tempe AZ 85281
• MDR Report Key: 9137750
• Report Number: 2020394-2019-03636
• Device Sequence Number: 2782189
• Product Code: NEU
• UDI-Device Identifier: 00801741032301
• UDI-Public: (01)00801741032301
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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 Model Number: 864017
• Device Catalogue Number: 864017
• Device Lot Number: HUCX0340
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: Required Intervention