MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SENOMARK BIOPSY SITE MARKERS; BIOPSY INSTRUMENT

Model Number SMEC10GSS

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(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 during a mammographic-guided breast biopsy for a small cluster of calcifications, the marker allegedly failed to advance, failed to deploy, and afterwards failed to be removed from the probe.Reportedly, the patient was given more local anesthesia (lidocaine) and the probe and a portion of the marker were removed as one unit from the patient, while the cutter was open.Post procedure imaging indicated that a portion of the marker was allegedly sheared off by the cutter and now remains in the patient.There was no reported patient injury.

• Brand Name: SENOMARK BIOPSY SITE MARKERS
• Type of Device: BIOPSY INSTRUMENT
• 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: 7580884
• MDR Text Key: 110455863
• Report Number: 2020394-2018-00822
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00801741031915
• UDI-Public: (01)00801741031915
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMEC10GSS
• Device Catalogue Number: SMEC10GSS
• Device Lot Number: VTBX00459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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