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

Catalog Number SMEC10C

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The device has not been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event 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 deployment, the marker applicator allegedly had a small plastic bead on the tip.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and the reported lot met all release criteria.Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, a 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: 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 instructions for use, the device contains three resorbable polyglycolic acid (pga) pads and one polyethylene glycol (peg) push pellet.However, based on the available information, the definitive root cause is unknown.It is unknown whether procedural issues at the facility contributed to the event.Labeling review: the current senomark ultra breast biopsy marker instructions for use (ifu) states: the senomark® ultra breast tissue marker consists of a disposable applicator containing: ¿ - 3 resorbable polyglycolic acid (pga) pads that are essentially resorbed in approximately 12 weeks.The center pad contains a titanium or biodur¿ 108 wireform with an interwoven polyvinyl alcohol (pva) polymer for permanent ultrasound enhancement.Please note the (pva) polymer is not resorbed.¿ - 1 polyethylene glycol (peg) push pellet.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.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.How supplied - the senomark® ultra breast tissue marker is provided sterile and non-pyrogenic unless the package has been opened or damaged.Sterilized by using irradiation.For single use only.Do not reuse.Do not resterilize.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 deployment, the marker applicator allegedly had a small plastic bead on the tip.There was no reported patient injury.

• Brand Name: SENOMARK ULTRA 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: 6530511
• MDR Text Key: 74096446
• Report Number: 2020394-2017-00382
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032028
• UDI-Public: (01)00801741032028(17)190801(10)VTAV00461
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: SMEC10C
• Device Lot Number: VTAV00461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2016
• 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