MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	SDAN1000
Medical Device Problem Codes	Positioning Failure (1158); Application Network Problem (2879)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a procedure, the two needles had difficulty deploying, and did not get any tissue sample.It was noted that the nodule characteristics (hard tissue) or were not in the correct spot for deployment.The physician was able to complete the electromagnetic navigational bronchoscopy (enb) portion of the case.However, after the procedure, the patient had pneumothorax which resulted in extended hospitalization.To resolve the issue, a chest tube was used.
Additional Manufacturer Narrative
D10 concomitant product: (b)(6) superd asp needle 21g 0.813mm (lot#sd0623174) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SUPERDIMENSION
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19044345
• Report Number: 3004962788-2024-00019
• Device Sequence Number: 7223004
• Product Code: GAA
• UDI-Device Identifier: 10884521843196
• UDI-Public: 10884521843196
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K860582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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: SDAN1000
• Device Catalogue Number: SDAN1000
• Device Lot Number: SD0423111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Male