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

Lot Number UNKNOWN

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

Patient Problem Blood Loss (2597)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

The customer disposed of the product and it was not returned.Therefore, the complaint could not be confirmed, and no root cause could be determined.The model and lot number is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure, a pass was made with cytology brush.After biopsy the patient had bleeding and the procedure was ended.The physician attributed the bleeding to a vascular lesion.An open thoracotomy was performed to remove the bleeding lobe and the patient was hospitalized.There was no device issue reported.

• Brand Name: SUPERTRAX CYTOLOGY BRUSH
• 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: amy beeman ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 7632104064
• MDR Report Key: 8051093
• MDR Text Key: 126542577
• Report Number: 3004962788-2018-00064
• 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: 11/08/2018

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/08/2018
• 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
• Treatment: SUPERDIMENSION INREACH SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR