MAUDE Adverse Event Report: HOBBS MEDICAL, INC. UNKOWN CYTOLOGY BRUSH

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

Patient Problems Pneumothorax (2012); Bronchial Hemorrhage (4456)

Event Type  Injury  

Event Description

According to the literature, prospective study evaluated the role of operators' experience as well as lesion- and procedure characteristics on diagnostic yield of electromagnetic navigation bronchoscopy (enb) procedures in the hands of novice enb operators.Patients underwent enb procedures between may 2018 and february 2020.All procedures were performed using the superdimension navigation system 7.1.215 procedures were performed with forceps used in 190 patients, needle used in 42 patients and cytobrushes used in 120 patients.Complications included: bronchial hemorrhage requiring a balloon catheter in 1 patient and pneumothorax requiring chest tube insertion in 2 patients.Publication title: diagnostics.Article title: when pulmonologists are novice to navigational bronchoscopy, what predicts diagnostic yield? date: 12 december 2022.Hobbs medical brushes are distributed as superdimension-branded accessories to the superdimension navigation system.No malfunction of any device was reported.

Manufacturer Narrative

Waiting confirmation from study author to confirm if hobbs medical devices were involved.

• Brand Name: UNKOWN CYTOLOGY BRUSH
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer (Section G): HOBBS MEDICAL, INC.; 8 spring street; stafford springs CT 06076
• Manufacturer Contact: jennifer hodge ; 8 spring st.; stafford springs, CT 06076 ; 8606845875
• MDR Report Key: 16589479
• MDR Text Key: 311743247
• Report Number: 1220592-2023-00002
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/22/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention