MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D; BREAST BIOPSY SYSTEM

Model Number PBX-SYS-AFFIRM-3D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021 a (b)(6) female patient had a right cc (from below) biopsy of a posterior lesion.Patient described discomfort on her rib area at time of positioning, adjustments of sheet made by both mit and patient, patient consented to continue biopsy procedure.Patient felt pain more severely midway through biopsy and struggled to get up off the bed once procedure was completed.Patient later reported to the customer on (b)(6) 2021 indicating she had ended up with 3 fractured ribs on the anterio-lateral aspects of 9th/10th ribs region (x-rayed on (b)(6) 2021).Patient also indicated in her complaint, that at the time of her procedure "it was not my right breast that was hurting, but something was hurting on my right side." additional informaton received from the customer noted "we thought the missing vinyl cushions we used to provide comfort could've been part of the reason.Vinyl cushions were lost/thrown out with dirty linen in (b)(6) 2021 and new ones did not arrive until (b)(6) 2021 as they had to be custom made.Sheet and gel pads were used for comfort during this case.Doctors referred patient for bone density scan and dr porter confirmed patient was osteoporotic, so we thought this could be a contributing factor." this event was reported to hologic on (b)(6) 2021.A field engineer was dispatched to the site and an initial evaluation did not find any mechanical or physical issues with the system.Discussions with the customer determined the provided hologic padding was not being used and additional application training was completed regarding the use of the correct padding as well as alternative positioning techniques that can be considered.As of today this investigation is still in progress.

Event Description

The customer reported that the tabletop felt more rigid on one side than the other.The aperture comfort inserts were replaced.The customer tried the table with the new 12.5cm round hole insert and said it felt much better and will continue to monitor.The replaced comfort inserts have been requested to be returned to hologic for evaluation.

Manufacturer Narrative

The insert was returned to hologic for evaluation.Visual evaluation indicated signs of multiple usage and wear.Currently, hologic is only aware of 3 complaints of this kind; all of them from one location, on one system, over a 9-month period.Based upon the health risk assessment, not using the provided padding can potentially result in rib injury for patients with pre-existing health issues.The probability of broken ribs is believed to be extremely remote and current instructions state to use cushions.Therefore, a remedial action assessment (raa) is not required.A definitive root cause cannot be determined.Hologic strives for continuous improvement and will continue to monitor and trend for safety.

• Brand Name: AFFIRM PRONE BIOPSY SYSTEM, 3D
• Type of Device: BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 12447520
• MDR Text Key: 271463565
• Report Number: 1220984-2021-00037
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K153486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PBX-SYS-AFFIRM-3D
• Device Catalogue Number: PBX-SYS-AFFIRM-3D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female