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	Pneumothorax (2012); Respiratory Failure (2484); No Code Available (3191)
Date of Event	07/01/2015
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.Title electromagnetic navigational bronchoscopy: a safe and effective method for fiducial marker placement in lung cancer patients source the american surgeon.Volume 81 pages 659-662.Date of publication: july 2015.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source of study, the safety and effectiveness of enb when used in fiducial marker placement.Sixty-four patients in this study had a total of 68 lung lesions.190 fiducial markers in these lesions.All fiducials placed were divided into two groups, those placed in the upper lobes and those placed in their middle and lower lobes.There were three (5%) unplanned hospital admissions; two patients with upper lobe markers and one patient with a lower lobe marker.One patient from each group (3%) suffered from respiratory failure and two patients (3%) with markers placed in the upper lobes developed a pneumothorax.

• 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: 8499949
• Report Number: 3004962788-2019-00020
• Device Sequence Number: 2515840
• Product Code: JAK
• UDI-Device Identifier: 10884521539709
• UDI-Public: 10884521539709
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/10/2019
• 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; Other
• Patient Age: 74 YR