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

Catalog Number 864017

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 04/30/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number is unknown.Visual inspection: a visual inspection could not be performed as the device was not returned.Functional/performance evaluation: a functional/performance evaluation could not be performed as the device was not returned.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.Per the reported event details, the patient disclosed that they had an allergy to nickel post-implantation.The current instructions for use (ifu) states: "as with any foreign object implanted into the body, potential adverse reactions are possible.It is the responsibility of the physician to evaluate the risk/benefit prior to the use of this device." therefore, it is likely that patient issues contributed to the reported event.However, based upon the available information, the definitive root cause could not be determined.Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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, the patient allegedly developed a rash at the site of the marker placement, which she treated (corticosteroid cream).It was further reported that the physician currently sees no sign of a rash.Allegedly, the patient was prescribed an antibiotic.The marker remains implanted.

• Brand Name: ULTRACLIP II BREAST TISSUE MARKER
• Type of Device: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 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 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5676576
• MDR Text Key: 45820866
• Report Number: 2020394-2016-00463
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 864017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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