MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Model Number SDTNB1500

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

Patient Problem Pneumothorax (2012)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The lot number was unknown.Pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient received was pneumothorax.Multiple tools were used for biopsy.The physician was able to complete the case successfully.The patient visited emergency room (er) in the evening on (b)(6) 2019.A pigtail was placed.

• Brand Name: SUPERDIMENSION
• Type of Device: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• 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: 8279568
• MDR Text Key: 134179392
• Report Number: 3004962788-2019-00002
• Device Sequence Number: 1
• Product Code: BTG
• UDI-Device Identifier: 20884521200552
• UDI-Public: 20884521200552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130357
• 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
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SDTNB1500
• Device Catalogue Number: SDTNB1500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2019
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 53