MAUDE Adverse Event Report: INFUS MEDICAL (THAILAND) STARCHMARK BREAST TISSUE MARKER; BREAST TISSUE MARKERS

Model Number	STMKEC10GSS
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.The device has 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 or Problem Description
It was reported that during breast tissue marker deployment, the plunger was allegedly difficult to deploy the marker and once removed from probe the pellet and marker fell out.It was further reported that the applicator was bent and cracked.There was no reported patient injury.
Event or Problem Description
It was reported that during breast tissue marker deployment, the plunger was allegedly difficult to deploy the marker and once removed from probe the pellet and marker fell out.It was further reported that the applicator was bent and cracked.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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one starchmark applicator was received for evaluation.The marker applicator was received in two segments, one within the probe used in the event.The marker applicator was removed from the probe without issue, no breaks or cracks were noted.However, it was noted the distal tip was detached.It is likely the detachment was perceived as a break and crack.The marker applicator was examined via x-ray, and noted the wireform to be present within the aperture.Functional testing could not be performed due to the returned sample condition (e.G., detached distal tip).Therefore, the investigation is confirmed for the reported detachment based on the returned sample condition.Furthermore, the investigation is inconclusive for the reported deployment difficulties and failure to separate issue as functional testing could not be performed due to the returned sample condition.Additionally, the investigation is unconfirmed for the reported break and crack.The definitive root cause for the reported detachment, deployment, and separation issues could not be determined based upon the provided information.It is unknown whether procedural issues contributed to the event.Label review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: STARCHMARK BREAST TISSUE MARKER
• Common Device Name: BREAST TISSUE MARKERS
• Manufacturer (Section D): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• MDR Report Key: 7763091
• Report Number: 2020394-2018-01403
• Device Sequence Number: 1860804
• Product Code: NEU
• UDI-Device Identifier: 00801741032165
• UDI-Public: (01)00801741032165
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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
• Operator of Device: Health Professional
• Device Model Number: STMKEC10GSS
• Device Catalogue Number: STMKEC10GSS
• Device Lot Number: VTBZ00529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1