MAUDE Adverse Event Report: HOLOGIC CELERO BREAST BIOPSY DEVICE

Catalog Number CELERO-12

Device Problem Difficult to Insert (1316)

Patient Problem Hematoma (1884)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

It was reported that during a celero breast biopsy procedure, the physician experienced difficulty removing tissue with the disposable device.The needle went into the breast and then went backwards.The physician re-cocked and at this point "blood started to pour out of the handle".The pt got a "large hematoma".The procedure was completed with a second device.No medical staff injury.No medical intervention was required.The "pt was fine" and discharged home.

Manufacturer Narrative

The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant info is received, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported lot number.The lot was released meeting all qa specifications.Currently unable to establish a relationship or impact to the reported observation.(b)(4).

• Brand Name: CELERO BREAST BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, manager ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3716562
• MDR Text Key: 4337806
• Report Number: 1222780-2014-00027
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2015
• Device Catalogue Number: CELERO-12
• Device Lot Number: 310003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/28/2014
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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
• Patient Outcome(s): Other