MAUDE Adverse Event Report: SUPERDIMENSION, INC SUPERDIMENSION SUPERLOCK COBRA; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	SDGN447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was disposed of and was not returned for evaluation.Not lot number was provided.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.
Event or Problem Description
Patient had a post-procedure right-sided pneumothorax after a superdimension enb procedure.The physician attributed the event to the placement of a superlock cobra fiducial marker.The patient was admitted for 1 night for observation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The medical monitor reported the patient had a planned hospital stay and it was not related to the pneumothorax.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERDIMENSION SUPERLOCK COBRA
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SUPERDIMENSION, INC; 161 cheshire lane, suite 100; minneapolis MN 55441
• MDR Report Key: 6391426
• Report Number: 3004962788-2017-05016
• Device Sequence Number: 33989
• Product Code: JAK
• UDI-Device Identifier: 10884521539709
• UDI-Public: 10884521539709
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2017

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
• Operator of Device: Health Professional
• Device Model Number: SDGN447
• Device Catalogue Number: SDGN447
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: 02/10/2017; 02/10/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 07/18/2017; 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CYTOLOGY BRUSH, UNKNOWN BIOPSY FORCEPS
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR