MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERDIMENSION INREACH BRONCHUS SYSTEM; ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY

Model Number AAS00161-12

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.There were no anomalies identified during the internal review of the dhr of the system console.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If additional information is received a follow-up report will be submitted.

Event Description

The patient suffered a pneumothorax during a superdimension procedure.The patient was hospitalized and released.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

Per the physician, the patient's nodule was very peripheral and there was an increased risk of pneumothorax due to the location.They were unsuccessful in obtaining tissue for biopsy from this site.The patient required a chest tube for the pneumothorax and was admitted overnight for observation.The patient received oxygen as standard of care for every patient that has a pneumothorax.The patient was discharged from the hospital the next day and had returned to baseline.The md has since seen the patient and he reports she is doing well.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

• Brand Name: SUPERDIMENSION INREACH BRONCHUS SYSTEM
• Type of Device: ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 5470072
• MDR Text Key: 39373645
• Report Number: 3004962788-2016-00035
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AAS00161-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 55 YR