MAUDE Adverse Event Report: HOLOGIC, INC SMARK-ATEC; BREAST BIOPSY MARKER

Catalog Number SMARK-A1309-SS1

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Lot number of the device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the lot number was not provided by the complainant.If additional relevant information is received, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported a physician performed an atec breast biopsy procedure sometime in (b)(6) 2015 and placed a smark marker.The patient was discharged home.Sometime post procedure, the patient "patient states that the marker has caused pain in her feet and rashes to appear on her feet and palms.The rashes come and go".The patient was also complaining of other symptoms that were not related to the procedure (exact symptoms unknown).No other information provided.We have been unable to obtain additional information surrounding this.

• Brand Name: SMARK-ATEC
• Type of Device: BREAST BIOPSY MARKER
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6327896
• MDR Text Key: 67321557
• Report Number: 1222780-2017-00038
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K07293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SMARK-A1309-SS1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/13/2017
• 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
• Treatment: ATEC HAND PIECE - LOT# UNK
• Patient Outcome(s): Other