MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERTRAX NEEDLE TIP CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number	AKI00100-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patent was desaturated to 83%, with surgical emphysema and respiratory distress.No chest sounds on the left side.
Additional Manufacturer Narrative
The device was not returned for evaluation.The incoming inspection records were 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 or Problem Description
A patient received a large left pneumothorax during a superdimension enb procedure.A chest drain was inserted.
Event or Problem Description
The site reports that the pneumothorax resolved on (b)(6) 2016.

• Brand Name: SUPERTRAX NEEDLE TIP CYTOLOGY BRUSH
• Common Device Name: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• MDR Report Key: 6053498
• Report Number: 3004962788-2016-00281
• Device Sequence Number: 75369
• Product Code: FDX
• UDI-Device Identifier: 10884521200463
• UDI-Public: 10884521200463
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K834402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2016

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
• Operator of Device: Health Professional
• Device Model Number: AKI00100-01
• Device Lot Number: SD1115175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 10/25/2016; 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR