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

Model Number	AKI00100-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing records could not be reviewed as no lot information was provided.Could not confirm if complications described in the article involved the device referenced herein, or competitor's products.Complications described are known risks of the procedure, within typical rates of occurrence.
Event or Problem Description
According to the literature, a retrospective study examined 200 consecutive patients referred for cone beam ct bronchoscopic biopsy of peripheral lung lesions between april 2021 and november 2021.The company's catheter were used in the first 85 patients and a competitor device was used in the next 115 patients.The biopsy approach included an extended multimodality approach, including in order the following: fine needle aspirate for 8 passes using the company's pulmonary needle or a competitor needle, cytology brush using the company's cytology brush, transbronchial forceps biopsies were performed using the company's forceps or a competitor device.Postoperative complications included.Bleeding in one patient.The patient with bleeding developed postoperative hypoxemia and required over-night hospitalization.The patient also required topical traxemenic acid and topical epinephrine.

• Brand Name: SUPERDIMENSION CYTOLOGY BRUSH
• Common Device Name: 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 street; stafford springs, CT 06076 ; 8606845875
• MDR Report Key: 19704645
• Report Number: 1220592-2024-00004
• Device Sequence Number: 12760295
• Product Code: FDX
• UDI-Device Identifier: 10884521200463
• UDI-Public: 10884521200463
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K834402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Literature,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: AKI00100-01
• Device Catalogue Number: AKI00100-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown