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

Model Number	SDGN447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Pneumothorax (2012); Unintended Radiation Exposure (4565)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the physician deployed two markers, and the patient seemed fine and fluro looked fine.The physician was able to complete the enb portion of the case, however six hours later the patient presented in the emergency room (er) with chest pain, and x-ray showed the marker in the pleura caused pneumothorax.To resolve the surgeon had to put chest tube and due to the issue, the patient extended patient hospitalization for a night.

• Brand Name: SUPERLOCK
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 11087113
• Report Number: 3004962788-2020-00073
• Device Sequence Number: 16827134
• Product Code: JAK
• UDI-Device Identifier: 10884521539709
• UDI-Public: 10884521539709
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SDGN447
• Device Catalogue Number: SDGN447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention