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

Model Number	SD180EWCTE-FT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.However the reported behavior is consistent with a known issue in which an internal corrective action was initiated.
Event or Problem Description
Site reported a string-like fiber from the extended working channel catheter came out while biopsying during a superdimension enb procedure.The site reported nothing was left behind in the patient.There was no report of patient injury, death, or other serious adverse event.
Additional Manufacturer Narrative
The product was returned on (b)(6) 2017 and evaluated.The evaluation showed peeling of the liner.This is consistent with an existing internal capa.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE CATHETER SYSTEM
• 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: 6642854
• Report Number: 3004962788-2017-05062
• Device Sequence Number: 1123498
• Product Code: JAK
• UDI-Device Identifier: 10884521199491
• UDI-Public: 10884521199491
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K102604
• 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,Followup
• Report Date (Section B): 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD180EWCTE-FT
• Device Catalogue Number: SD180EWCTE-FT
• Device Lot Number: E103947
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/15/2017
• 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