MAUDE Adverse Event Report: SURGICAL SPECIALTIES MÉXICO / ANGIODYNAMICS BIOSENTRY TRACT SEALANT SYSTEM; ABSORBABLE LUNG BIOPSY PLUG

Model Number 768022019S

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

During use by physician for a lung biopsy, the device would not deploy.Removed from the field.No patient harm.

Event Description

During use by physician for a lung biopsy, the device would not deploy.Removed from the field.No patient harm.

• Brand Name: BIOSENTRY TRACT SEALANT SYSTEM
• Type of Device: ABSORBABLE LUNG BIOPSY PLUG
• Manufacturer (Section D): SURGICAL SPECIALTIES MÉXICO / ANGIODYNAMICS; 24 native dr; queensbury NY 12804
• MDR Report Key: 14218301
• MDR Text Key: 290171002
• Report Number: 14218301
• Device Sequence Number: 1
• Product Code: OMT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 768022019S
• Device Catalogue Number: 768022019S
• Device Lot Number: 5692710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2022
• Date Report to Manufacturer: 04/27/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA