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 Hemoptysis (1887)

Event Date 06/27/2015

Event Type  Injury  

Manufacturer Narrative

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

A patient reported that 3 days after a superdimension enb procedure, she experienced three episodes of hemoptysis.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

Manufacturer Narrative

This event did not require medical intervention and does not meet the criteria for a serious injury therefore is not a reportable event.

• 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: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 5704322
• MDR Text Key: 46738195
• Report Number: 3004962788-2016-00143
• 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: 06/07/2016

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: 05/12/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• 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
• Patient Age: 76 YR