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

Model Number AKI00100-01

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

Patient Problem Pneumothorax (2012)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the appropriate device history records of the superdimension console indicates this device was released meeting all quality specifications.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.

Event Description

A patient pneumothorax was discovered after a superdimension enb procedure.A chest tube was required and the patient was hospitalized.Physician was unable to determine what caused the pneumothorax.Patient also reported to have left lower lobe pneumonia and right pleura infusion and now moving forward to vats.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERTRAX NEEDLE TIP 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: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 6629246
• MDR Text Key: 77215002
• Report Number: 3004962788-2017-05060
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 10884521200463
• UDI-Public: 10884521200463
• 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,Followup
• Report Date: 05/15/2017

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: AKI00100-01
• Device Catalogue Number: AKI00100-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 05/15/2017
• Supplement Dates FDA Received: 10/04/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 78