MAUDE Adverse Event Report: INFUS MEDICAL (THAILAND) SENOMARK ULTRA BREAST TISSUE MARKER; BIOPSY INSTRUMENT

Model Number	SMEC10R
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(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 or Problem Description
It was reported that during preparation of a stereotactic breast biopsy, the device allegedly was observed to be bent.It was further reported that an attempt was made to deploy the device and it allegedly failed to deploy and was difficult to remove from the applicator.The procedure was concluded without any marker placed.There was no reported patient injury.
Event or Problem Description
It was reported that during preparation of a stereotactic breast biopsy, the device allegedly was observed to be bent.It was further reported that an attempt was made to deploy the device and it allegedly failed to deploy and was difficult to remove from the applicator.The procedure was concluded without any marker placed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.However requested.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.Investigation summary: one partial senomark ultra marker applicator was returned for evaluation.The returned marker applicator was received severely stretched with the distal end detached.The detached segment was not returned for evaluation.No marker pga pads or wireform were returned for evaluation.Therefore, the investigation is confirmed for the reported removal issues and identified detachment, due to the returned sample condition (e.G., sever stretching and detached segment).Additionally, the investigation is inconclusive for the reported failure to deploy issue and bent applicator.Per the reported event details, before use, the marker appeared bent upon opening.It is highly likely user related issues (e.G., use of damaged marker) contributed to the reported deployment failure and it is likely the reported removal difficulties contributed to the identified detachment.However, the definitive root cause for the reported and identified failures could not be determined based upon the provided information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Section a through f - the information provided by bd 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 bd.

• Brand Name: SENOMARK ULTRA BREAST TISSUE MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• MDR Report Key: 7887718
• Report Number: 2020394-2018-01739
• Device Sequence Number: 2488810
• Product Code: NEU
• UDI-Device Identifier: 00801741032035
• UDI-Public: (01)00801741032035
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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
• Operator of Device: Health Professional
• Device Model Number: SMEC10R
• Device Catalogue Number: SMEC10R
• Device Lot Number: VTBQ00136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1