MAUDE Adverse Event Report: HOLOGIC, INC ATEC INTRODUCER LOCALIZATION SET SURESIGHT; SURGICAL NEEDLE GUIDE

Model Number 0914-20-OB

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

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.Currently unable to establish a relationship or impact to the reported observation.(b)(4).

Event Description

It was reported during a breast biopsy procedure on (b)(6) 2016, the obturator "tip broke off" inside the sheath prior to inserting into the patient.The procedure was completed with a second device."no report of patient injury".

Manufacturer Narrative

The returned device was received and visually inspected.The investigator verified that the distal tip of the obturator is broken.Cause is presently unknown for failure.The reported observation was confirmed.This observation is being trended and monitored.

• Brand Name: ATEC INTRODUCER LOCALIZATION SET SURESIGHT
• Type of Device: SURGICAL NEEDLE GUIDE
• 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: 5706553
• MDR Text Key: 48057302
• Report Number: 1222780-2016-00142
• Device Sequence Number: 1
• Product Code: GDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/08/2016
• Device Model Number: 0914-20-OB
• Device Catalogue Number: ILS 0914-20-OB
• Device Lot Number: 604558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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