MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number	KCFW-7.0-35-55-RB-HFANL0-HC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
Physician had access in the common femoral artery with a glide wire up and over the bifurcation.Tech prepped the sheath and had dilator loaded into the sheath.At the point where the sheath was going to be loaded onto the wire, the physician noted the tip of sheath looked to have a deformity.The sheath was not advanced into the patient.A new sheath was used to successfully complete the procedure.Images of the device depicted jagged edges at the tip of sheath.The patient did not experience any adverse effects due to the occurrence.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6567349
• Report Number: 1820334-2017-01138
• Device Sequence Number: 10946823
• Product Code: DYB
• UDI-Device Identifier: 00827002562325
• UDI-Public: (01)00827002562325(17)180420(10)5820215
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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 Catalogue Number: KCFW-7.0-35-55-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1