MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERTRAX NEEDLE TIP CYTOLOGY BRUSH (10 IN A PACK); ENDOSCOPIC CYTOLOGY BRUSH

Model Number SDNB2000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pneumothorax (2012)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.There was no lot number 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

The patient suffered a pneumothorax during a superdimension procedure.The patient received a chest tube and was hospitalized for two nights and released.The physician stated that the lesion was pleura based and possibly attributed the event to the needle tipped brush.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

• Brand Name: SUPERTRAX NEEDLE TIP CYTOLOGY BRUSH (10 IN A PACK)
• 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: 5537469
• MDR Text Key: 41521818
• Report Number: 3004962788-2016-00069
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SDNB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 17