MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK ULTRACOR MARKER; BREAST TISSUE MARKER

Model Number	SMUC10H
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Reaction, Injection Site (2442)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the sample was not returned for evaluation.Therefore, the investigation is inconclusive for the reported reaction issue.Per the reported event details, the patient stated she has not been able to wear metal jewelry for years however no confirmation of any allergies was provided.Per the instructions for use, the device contains a resorbable polyglycolic acid (pga) pad, one biodur 108 wireform, and one interwoven polyvinyl alcohol (pva) polymer.Additionally, the ifu states, "patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant".Therefore it is likely patient factors contributed to this event.However, based upon the available information, the definitive root cause is unknown.Labeling review: the current senomark ultracor breast tissue marker instructions for use (ifu) state: general information and device description: -the marker contains a resorbable polyglycolic acid (pga) pad with a wireform that includes an interwoven polyvinyl alcohol (pva) polymer for permanent ultrasound enhancement.The pga pad is essentially resorbed in approximately 12 weeks.Please note the pva polymer is not resorbed.Contraindications: -patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant.Warnings: -do not use in the presence of infection.-this device has been designed for single use only.Reuse of this device bears the risk of cross-patient contamination, as medical devices with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean.The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.Precautions: this product should only be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of breast tissue marker placement.Potential complications: -complications may occur at any time during or after the procedure.Potential complications of breast tissue marker placement may include, but are not limited to hematoma, hemorrhage, infection, adjacent tissue injury and pain.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, the patient allegedly may have a hematoma and is experiencing itching, swelling, and warmth at the injection site.The physician was advised and started the patient on antibiotics.

• Brand Name: SENOMARK ULTRACOR MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6913887
• Report Number: 2020394-2017-01274
• Device Sequence Number: 13805022
• Product Code: NEU
• UDI-Device Identifier: 00801741032394
• UDI-Public: (01)00801741032394
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K050090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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 Expiration Date: 03/01/2020
• Device Model Number: SMUC10H
• Device Catalogue Number: SMUC10H
• Device Lot Number: VTBQ00110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 10/04/2017
• 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
• Patient Age: 51 YR
• Patient Weight: 76