MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERDIMENSION INREACH SYSTEM; ELECTROMAGNITIC NAVIGATION BRONCHOS

Model Number AAS00161-20

Device Problem Device Inoperable (1663)

Patient Problems Death (1802); Pneumothorax (2012)

Event Date 06/04/2014

Event Type  Death  

Event Description

The customer originally reported that during a superdimension procedure on (b)(6) 2014, the system shut down unexpectedly.In addition, the pt sustained a pneumothorax during this procedure but the site stated the system shut down did not contribute to the pt's pneumothorax.The pt subsequently expired in the hosp on (b)(6) 2014.Add'l questions have been extended to the site, if add'l info pertinent to the incident is obtained a f/u report will be submitted.

Manufacturer Narrative

The incident device has been received and is under eval.When the device eval is complete a f/u report will be submitted.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.

• Brand Name: SUPERDIMENSION INREACH SYSTEM
• Type of Device: ELECTROMAGNITIC NAVIGATION BRONCHOS
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane north; suite 100; minneapolis MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane north; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 3928573
• MDR Text Key: 4534913
• Report Number: 3004962788-2014-00034
• 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: 06/27/2014

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: AAS00161-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2011
• 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): Death
• Patient Age: 76 YR