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

Model Number SMUC10H

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction, Injection Site (2442)

Event Date 08/28/2017

Event Type  Injury  

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 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
• Type of Device: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6913887
• MDR Text Key: 88139319
• Report Number: 2020394-2017-01274
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032394
• UDI-Public: (01)00801741032394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 76