MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP II BREAST TISSUE MARKER; IMPLANTABLE CLIP

Catalog Number	864017
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and not medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that post breast tissue marker placement into normal density tissue, the marker allegedly could not be seen under mammogram.It was further reported that the procedure was completed by placing another marker and a coaxial was not used.There was no reported patient injury.
Additional Manufacturer Narrative
After further review of the event details, it was determined that the inability to see a tissue marker under mammogram (1408 - poor quality image) is not an issue that is likely to cause or contribute to a serious patient injury.There was no reported patient injury.This event was reassessed and determined to be not mdr reportable.However, a supplemental mdr has already been submitted; therefore, the purpose of this supplemental report is to document the change in reportability classification.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that post breast tissue marker placement into normal density tissue, the marker allegedly could not be seen under mammogram.It was further reported that the procedure was completed by placing another marker and a coaxial was not used.There was no reported patient injury.

• Brand Name: ULTRACLIP II BREAST TISSUE MARKER
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6419737
• Report Number: 2020394-2017-00221
• Device Sequence Number: 36417
• Product Code: NEU
• UDI-Device Identifier: 00801741032301
• UDI-Public: (01)00801741032301(17)190728(10)HUAV1054
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 864017
• Device Lot Number: HUAV1054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1