MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERDIMENSION TRIPLE NEEDLE CYTOLOGY BRUSH; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Model Number SDTNB1000

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

Patient Problem Pneumothorax (2012)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.There were no anomalies identified during the internal review of the incoming inspection records for the triple needle brush, the biopsy needle, or the biopsy forceps.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 small left apical pneumothorax during a superdimension procedure.The pneumothorax was treated with a chest tube.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

• Brand Name: SUPERDIMENSION TRIPLE NEEDLE CYTOLOGY BRUSH
• Type of Device: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• 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: 5675828
• MDR Text Key: 45787599
• Report Number: 3004962788-2016-00128
• Device Sequence Number: 1
• Product Code: BTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• 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: RLT013599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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 GAUGE NEEDLE, SDBF1000
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR