MAUDE Adverse Event Report: SUPERDIMENSION INC. SUPERTRAX TRIPLE NEEDLE-TIPPED CYTOLOGY BRUSH

Catalog Number SDTNB1000

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/10/2014

Event Type  Injury  

Event Description

Site reported pt had bleeding post superdimension procedure.After biopsy pt had a 200 ml bleed requiring additional intervention.Thrombin was used to stop the bleeding and pt was released the same day.

Manufacturer Narrative

The product is not available for evaluation and will not be returned.There were no anomalies identified during an internal review of the lot history.Bleeding is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.

• Brand Name: SUPERTRAX TRIPLE NEEDLE-TIPPED CYTOLOGY BRUSH
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane north; suite 100; minneapolis MN 55441
• Manufacturer Contact: denise anderson ; 161 cheshire lane north; suite 100; minneapolis, MN 55441 ; 7632104061
• MDR Report Key: 3687492
• MDR Text Key: 4298599
• Report Number: 3004962788-2014-00015
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SDTNB1000
• Device Lot Number: SD11-13-088
• Other Device ID Number: RTL-009437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 67 YR
• Patient Weight: 66