MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; ENDOSCOPIC CYTOLOGY BRUSH

Model Number	SDNB2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597)
Date of Event	02/17/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for evaluation and the lot number is unknown.The product was discarded by the customer.
Event or Problem Description
The patient had an enb procedure for biopsy of a suspicious lesion and fiducial marker placement.The patient had a blood loss of approximately 350cc following biopsy with unknown needle tipped cytology brush and procedure was aborted.It is unknown what type of treatment was given to stop bleeding.The patient was extubated and taken to the recovery room where she subsequently arrested and died.No further details regarding the circumstances are available.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERDIMENSION
• Common Device Name: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 6420896
• Report Number: 3004962788-2017-05028
• Device Sequence Number: 16281842
• Product Code: FDX
• UDI-Device Identifier: 10884521200531
• UDI-Public: 10884521200531
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K834402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2017

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
• Operator of Device: Health Professional
• Device Model Number: SDNB2000
• Device Catalogue Number: SDNB2000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death