MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC GENCUT CORE BIOPSY SYSTEM; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	SDCT01
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number was not provided.A photo of the device appeared to show the gencut catheter experienced an axial force large enough to kink and twist the catheter.We are unable to determine the cause of the pneumothorax.Pneumothorax is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.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.
Event or Problem Description
A patient received a pneumothorax during a superdimension enb procedure.No medical intervention was required.The physician reported the gencut twisted and kinked and was unable to be pulled back into the catheter and scope.It had to be retracted as one whole unit.
Additional Manufacturer Narrative
The device was returned on (b)(6) 2017 and evaluated.The evaluation showed kinks were observed on the catheter.The cause for the kinks could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GENCUT CORE BIOPSY SYSTEM
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 6593484
• Report Number: 3004962788-2017-05056
• Device Sequence Number: 746378
• Product Code: EOQ
• UDI-Device Identifier: 10884521539716
• UDI-Public: 10884521539716
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142839
• 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,Followup
• Report Date (Section B): 05/05/2017

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: SDCT01
• Device Catalogue Number: SDCT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/13/2017
• 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: Other