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

Model Number	SDK4000-FT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return has been requested but has not yet been received.However, the reported behavior is consistent with a known issue in which an internal corrective action was initiated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, hair like plastic came out of the extended working channel catheter anytime something was introduced into the catheter, such as the locatable guide or biopsy tool.There was no injury to the patient.
Additional Manufacturer Narrative
The complaint was confirmed as was verified as scratching and peeling were found in the ewc liner.The peeling of the liner shows scratching which leads to peeling of the liner.The most likely cause of the peeling is the use of a sharp tool.However, without any tools returned the root cause cannot be determined.A dhr review was performed and no anomalies were identified pertaining to this failure.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 7907393
• Report Number: 3004962788-2018-00052
• Device Sequence Number: 16564831
• Product Code: JAK
• UDI-Device Identifier: 10884521545557
• UDI-Public: 10884521545557
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: SDK4000-FT
• Device Catalogue Number: SDK4000-FT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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