MAUDE Adverse Event Report: SUPERDIMENSION EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	178-9
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumothorax (2012); Blood Loss (2597)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation therefore no root cause could be determined.No lot number or serial number was provided.Pneumothorax and bleeding are known short-term complications 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 or Problem Description
According to a literature article, 32 consecutive patients were prospectively enrolled to assess the diagnostic yield of electromagnetic navigation bronchoscopy (enb) combined with transbronchial lung cryobiopsy (tblc) and to compare it with standard transbronchial biopsy (tbb) in pulmonary nodules of less than 2 cm in diameter.After insertion of a rigid bronchoscope, a guide sheath was first inserted through a flexible bronchoscope in the segmental bronchus close to the target nodule with the previously described enb technique.In three patients, they were unable to reach the target with the enb.As a consequence, the method was successful in 29 patients.Adverse events consisted in 15 mild or moderate bleedings and one pneumothorax.Bleeding was graded 1 and 2 in, respectively, eleven and four patients.Pneumothorax needing pleural drainage for three days was observed in one patient.

• Brand Name: EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SUPERDIMENSION; 161 cheshire ln ste 100; minneapolis MN 55441
• MDR Report Key: 8198896
• Report Number: 3004962788-2018-00077
• Device Sequence Number: 2056513
• Product Code: JAK
• UDI-Device Identifier: 10884521199491
• UDI-Public: 10884521199491
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K102604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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: 178-9
• Device Catalogue Number: SD180EWCTE-FT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/27/2018
• 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: SUPERDIMENSION INREACH SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention