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

Model Number AAS00161-12

Device Problem Unintended Movement (3026)

Patient Problem Pneumothorax (2012)

Event Date 01/14/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 the site notified superdimension of a reported pneumothorax post superdimension procedure.The patient's pneumothorax was confirmed via x-ray after the procedure.Patient received oxygen via chest tube and was hospitalized and discharged.

Manufacturer Narrative

Superdimension has requested devices for eval but has not received anything to date.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.A dhr review was performed and no anomalies were found.

• Brand Name: SUPERDIMENSION INREACH BRONCHUS SYSTEM
• Type of Device: ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane north; suite 100; minneapolis MN 55441 543
• Manufacturer (Section G): SUPERDIMENSION INC.; 161 cheshire lane north; suite 100; minneapolis MN 55441 543
• Manufacturer Contact: denise anderson ; 161 cheshire lane north; suite 100; minneapolis, MN 55441-5433 ; 7632104061
• MDR Report Key: 3678915
• MDR Text Key: 4237197
• Report Number: 3004962788-2014-00010
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2014

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
• Device Operator: Health Professional
• Device Model Number: AAS00161-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• 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
• Patient Age: 71 YR
• Patient Weight: 95