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

Model Number SDNB2000

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

Patient Problems Death (1802); Blood Loss (2597)

Event Date 02/17/2017

Event Type  Death  

Manufacturer Narrative

The device was not returned for evaluation and the lot number is unknown.The product was discarded by the customer.

Event 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.

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
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 6420896
• MDR Text Key: 70451561
• Report Number: 3004962788-2017-05028
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10884521200531
• UDI-Public: 10884521200531
• 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: 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
• Device Operator: Health Professional
• Device Model Number: SDNB2000
• Device Catalogue Number: SDNB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 02/20/2017
• Supplement Dates FDA Received: 09/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 90 YR