MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO BIOSENTRY TRACT SEALANT SYSTEM; ABSORBABLE LUNG BIOPSY PLUG

Catalog Number H787768022019S1

Device Problem Material Separation (1562)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.

Event Description

The account alleges a portion of the plunger stylet broke off within the patient.There was resistance while deploying the plug and usual force was used to remove it.The patient was sent for a consultation with a thoracic surgeon but since the patient was experiencing no symptoms due to the retained foreign body, the decision was made by the clinical staff to leave it in place.No attempt will be made to remove the ifb from this patient.The patient is doing well and is currently unbothered by the foreign body.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: BIOSENTRY TRACT SEALANT SYSTEM
• Type of Device: ABSORBABLE LUNG BIOPSY PLUG
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18366492
• MDR Text Key: 331339312
• Report Number: 3011642792-2023-00078
• Device Sequence Number: 1
• Product Code: QMT
• UDI-Device Identifier: 05051684016516
• UDI-Public: 5051684016516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN090007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H787768022019S1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• 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: Initial
• Patient Sequence Number: 1