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

Catalog Number 863017

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2017

Event Type  malfunction  

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 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.

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 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
• Type of Device: IMPLANTABLE CLIP
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6419736
• MDR Text Key: 70417575
• Report Number: 2020394-2017-00222
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032295
• UDI-Public: (01)00801741032295(17)190928(10)HUAX1054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Catalogue Number: 863017
• Device Lot Number: HUAX1054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1