MAUDE Adverse Event Report: SUPERDIMENSION INC. ENDOSCOPIC CYTOLOGY BRUSH; TRIPLE NEEDLE CYTOLOGY BRUSH 10MM

Model Number SDTNB1000

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

Patient Problems Dyspnea (1816); Pneumothorax (2012)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.There were no anomalies identified during the internal review of the device receiving inspection records.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 and was hospitalized.The patient experienced shortness of breath and a chest tube was placed with relief of symptoms.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

• Brand Name: ENDOSCOPIC CYTOLOGY BRUSH
• Type of Device: TRIPLE NEEDLE CYTOLOGY BRUSH 10MM
• 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: 5198759
• MDR Text Key: 30303204
• Report Number: 3004962788-2015-00110
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K834402
• 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
• Report Date: 11/03/2015

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: SDTNB1000
• Device Lot Number: RLT012530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SDAN2000 PRE-MARKED 19 G NEEDLE
• Patient Outcome(s): Hospitalization; Other; Required Intervention