MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE; 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	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during the sampling in a procedure, possible shavings or parts of catheter pulled out from catheter with sample from patient.The long string pieces that were clear in color.Pulled a total of 3-4 pieces out with samples from patient.The physician was able to complete the superdimension portion of the case.There is no patient harm.
Additional Manufacturer Narrative
Additional info: evaluation summary: the complaint issue of possible shavings or parts of catheter pulled out from catheter with sample was verified as scratches and peeling were found in the ewc liner, but no delamination of the liner was found.The scratch and peeling in the liner observed on the outer radius of the curve, which means that the most likely cause of the scratch and peeling was the passing of a tool with a sharp tip on it through the ewc.However, as no tools were mentioned or returned for evaluation, the root cause cannot be determined.The dhr review was performed and no anomalies were identified pertaining to this failure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• 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: 8702101
• Report Number: 3004962788-2019-00047
• Device Sequence Number: 2354182
• Product Code: JAK
• UDI-Device Identifier: 10884521545557
• UDI-Public: 10884521545557
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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
• Device Lot Number: 509494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1