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

Model Number	SDM2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemostasis (1895); Blood Loss (2597)
Date of Event	03/17/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the appropriate inspection records of the lot indicates this device was released meeting all quality specifications.Bleeding 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
The patient had an enb procedure on (b)(6) 2011.Nine days following the procedure, the patient presented at the hospital with hemoptysis and a major hemostasis from a blood clot on the right side near the location of the target lesion.The patient was hospitalized and required ventilator support.Embolization was performed on (b)(6) 2011.The doctor did not allege any system deficiency, however new information received attributed the hemoptysis to the placement of the fiducial marker.The patient recovered and was subsequently discharged 1-2 days after the embolization.

• Brand Name: SUPERDIMENSION
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 6791198
• Report Number: 3004962788-2017-05076
• Device Sequence Number: 1116522
• Product Code: JAK
• UDI-Device Identifier: 10884521198791
• UDI-Public: 10884521198791
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K080271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2011

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: SDM2
• Device Catalogue Number: SDM2
• Device Lot Number: 101015-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2011
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention