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

Model Number AAS00161-20

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

Patient Problems Pneumothorax (2012); Respiratory Failure (2484); Blood Loss (2597)

Event Date 07/02/2019

Event Type  Injury  

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 improved diagnostic yield for lung nodules with digital tomosynthesis-corrected navigational bronchoscopy: initial experience with a novel adjunct source asian pacific society of respirology, 2019 (1-8) date of publication: 29 april 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source study performed to all consecutive enb procedures from 25 december 2017 to 25 august 2019 which is a retrospective review of the authors preliminary experience with fluoroscopic electromagnetic navigation bronchoscopy (f-enb) before and after its introduction at their institution to assess the impact on diagnostic yield and safety, f-enb was introduced on 25 april 2018.Two cohorts were analysed: standard enb (s-enb) from 25 december 2017 to 24 april 2018 and f-enb from 25 april 2018 to 25 august 2018.A total of 101 and 67 nodules were biopsied in the s-enb and f-enb groups, respectively.Complications were minimal and there were no differences seen between the groups.The most common complication was pneumothorax.In the s-enb group, there were 2 (1.9%) pneumothorax, 1 (0.9%) pneumothorax requiring chest tube, 1 (0.9%) unplanned admission, 1 (0.9%) bleeding requiring advanced intervention, and 1 (0.9%) respiratory failure.In the f-enb group, there were 1 (1.5%) pneumothorax and 1 (1%) pneumothorax requiring chest tube.

Manufacturer Narrative

Complaint was not confirmed.No product was returned therefore no root cause could be determined.A review of the appropriate device history records indicates this device serial/lot number was released meeting all quality specifications.Manufacturing non-conformances were reviewed.No entries pertinent to the customer's reports were noted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERDIMENSION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 8819896
• MDR Text Key: 152031318
• Report Number: 3004962788-2019-00055
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• Combination Product (y/n): N
• PMA/PMN Number: K173244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AAS00161-20
• Device Catalogue Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR