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

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

Patient Problem Pneumothorax (2012)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The lot number or model number was not provided therefore a dhr review was could not be completed.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

An x-ray showed the patient received a small rapical pneumothorax during a superdimension enb procedure.The patient was put on 100% oxygen.A repeat x-ray 2 hours later showed improvement and the patient was sent home asymptomatic.If additional information is obtained a follow-up report will be submitted.

Manufacturer Narrative

A device history record (dhr) for the concomitant product, gencut biopsy system, lot was reviewed and no anomalies were observed associated to this complaint.

• Brand Name: SUPERDIMENSION CYTOLOGY BRUSH
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• Manufacturer Contact: s murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 5746586
• MDR Text Key: 48096647
• Report Number: 3004962788-2016-00170
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR