MAUDE Adverse Event Report: HOLOGIC, INC. ATEC; 9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-12MR HANDPIECE

Model Number ILS 0914-12

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).

Event Description

It was reported a physician performed a breast biopsy procedure on (b)(6) 2018 and the tip of the plastic introducer remained inside the patient.The physician removed the piece and completed the procedure.There was no patient injury.The patient was discharged home.

Manufacturer Narrative

Corrected data in sections: common device name- numbers 2, 4.And g5, number 5.

• Brand Name: ATEC
• Type of Device: 9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-12MR HANDPIECE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7602845
• MDR Text Key: 111710334
• Report Number: 1222780-2018-00133
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045503199
• UDI-Public: (01)15420045503199(10)17F09R
• Combination Product (y/n): N
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/09/2019
• Device Model Number: ILS 0914-12
• Device Catalogue Number: ILS 0914-12
• Device Lot Number: 17F09R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1