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

Catalog Number SMEC10R

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

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, however the material found has been returned.As the lot number for the device was not provided, a review of the device history records was unable to be 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 after completing breast tissue marker placement, there was allegedly foreign white material found on the tip of the probe.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a full manufacturing review could not be conducted as the lot number is unknown.It is unknown if manufacturing contributed to the reported event.Visual inspection: the pellet was returned in a sample pouch, sealed by the user.The pellet was removed from the pouch and inspected under magnification.The pellet was measured and found to be approximately 0.105" in length, and 0.0469" in diameter.These dimensions do not meet the criteria for the peg pellet.However these measurements are not considered accurate dimensions of a finished pellet as handling of the material would have altered the dimensions of the device, as indicated by the rounded appearance of the material edges.Functional/performance evaluation: functional testing was not applicable, due to the nature of the complaint.The unidentified material was analyzed via ftir spectroscopy.The results indicated that the returned material was matched with 99.62 percent confidence to a senomark ultra peg pellet.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 investigation is unconfirmed for the reported foreign material, as the returned material was found to be a peg push pellet, which is not foreign to the returned device.It was determined that the returned material that was reported to be at the tip of the deployed device, was found to be the device peg pellet, which is not considered foreign material.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.(b)(4).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 after completing breast tissue marker placement, there was allegedly foreign white material found on the tip of the probe.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: 6362360
• MDR Text Key: 68471632
• Report Number: 2020394-2017-00114
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SMEC10R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1