MAUDE Adverse Event Report: COOK VASCULAR INC FLEXOR GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.(b)(4).The reported device returned for evaluation.Visual inspection notes the hub was detached from the sheath.A go-no-go gauge dimensional test was performed, which confirmed that the size of the flare met specification.Based on a visual inspection of the sheath, the flare appeared to be distorted, which is indicative of damage caused by the flare being pulled through the cap.It is feasible to suggest that the reported separation was caused by the device meeting resistance beyond its intended design.
Event or Problem Description
It was reported that the introducer become loose from the valve.Per additional information, the introducer detached from the valve.No fragments remained within the patient's body.

• Brand Name: FLEXOR GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6290355
• Report Number: 1820334-2017-00259
• Device Sequence Number: 798812
• Product Code: DYB
• UDI-Device Identifier: 00827002099944
• UDI-Public: (01)00827002099944(17)190209(10)NS6722066
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2016

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: N/A
• Device Catalogue Number: KCFW-8.0-38-80-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2016
• Initial Report FDA Received Date: 01/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1