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

Model Number	SMEC10R
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Reaction (2414)
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.Visual inspection:the sample was not returned; therefore, visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: image/photo was not provided; therefore, a review could not be performed.Conclusion: the sample was not returned.No photos were provided for review.Therefore, the investigation is inconclusive for the reported reaction issue.Per the reported event details, the patient stated to likely have a nickel allergy however no confirmation of the allergy was provided.Per the instructions for use, the device contains three resorbable polyglycolic acid (pga) pads, one polyethylene glycol (peg) push pellet, and one titanium or biodur 108 wireform.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 ultra breast tissue marker instructions for use (ifus) state: general information and device description: - the marker consists of 3 absorbable polyglycolic acid(pga) pads that are essentially resorbed in approximately 12 weeks.The center poad contains a titanium or biodur 108 wireform with an interwoven polyvinyl alcohol (pva) polymer for permanent ultrasound enhancement.- the wireform is intended for long-term radiographic marking of the biopsy site.The pva polymer is intended for long-term sonographic marking of the biopsy site.Contraindications: - patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant.Precautions: - the device should only be used by physicians trained in the percutaneous biopsy procedures.- do not use if the temperature indicator is black.Complications: - potential complications of breast tissue marker placement may include, but are not limited to: hematoma, hemorrhage, infection, adjacent tissue injury and pain.Directions for use: - confirm final breast tissue marker position with imaging.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 had an allergic reaction of swelling and rash around the area.It was further reported that the patient was treated with antibiotics.Reportedly, a few months later the marker was removed during a scheduled lumpectomy, following the lumpectomy the swelling and rash went away and have not returned.

• Brand Name: SENOMARK ULTRA MARKER
• Common Device Name: BREAST TISSUE MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6730514
• Report Number: 2020394-2017-00824
• Device Sequence Number: 19175264
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: 06/30/2016
• Device Model Number: SMEC10R
• Device Catalogue Number: SMEC10R
• Device Lot Number: VT15B0088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/20/2017
• 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