MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Model Number SDTNB1500

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

Patient Problem Pneumothorax (2012)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The incoming inspection record was reviewed and there were no anomalies observed associated to this issue.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.

Event Description

A patient was identified with pneumothorax post superdimension enb procedure.The patient was admitted to inpatient and a chest tube was placed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERDIMENSION
• Type of Device: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 6402159
• MDR Text Key: 69857834
• Report Number: 3004962788-2017-05021
• Device Sequence Number: 1
• Product Code: BTG
• UDI-Device Identifier: 10884521200555
• UDI-Public: 10884521200555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SDTNB1500
• Device Catalogue Number: SDTNB1500
• Device Lot Number: SD05-16-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 115