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

Model Number AKI00100-01

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

Patient Problem Pneumothorax (2012)

Event Date 09/20/2016

Event Type  Injury  

Event Description

Patent was desaturated to 83%, with surgical emphysema and respiratory distress.No chest sounds on the left side.

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 Description

A patient received a large left pneumothorax during a superdimension enb procedure.A chest drain was inserted.

Event Description

The site reports that the pneumothorax resolved on (b)(6) 2016.

• Brand Name: SUPERTRAX NEEDLE TIP CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• 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: 6053498
• MDR Text Key: 58272523
• Report Number: 3004962788-2016-00281
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10884521200463
• UDI-Public: 10884521200463
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K834402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AKI00100-01
• Device Lot Number: SD1115175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR