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

Model Number	SDAN1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number was not provided.Pneumothorax is a known short term complication 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 the reporter, the patient underwent a biopsy during an electromagnetic navigation bronchoscopy procedure and post-operatively, the patient had a pneumothorax.The physician completed the case successfully and it was not discovered until the patient was in post-op.A repeat ct scan was done and the pneumothorax was resolved.The patient was discharged same day.

• 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
• MDR Report Key: 7333531
• Report Number: 3004962788-2018-00011
• Device Sequence Number: 306387
• Product Code: GAA
• UDI-Device Identifier: 10884521200494
• UDI-Public: 10884521200494
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K860582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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: SDAN1000
• Device Catalogue Number: SDAN1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/13/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR