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

Catalog Number	KCFW-6.0-35-70-RB-HFANL1-HC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2016
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
Prior to patient contact, the complainant discovered that the distal tip of the introducer was deformed.The complainant also noted that the wire guide could not be inserted during sheath exchange and that the sheath had contact with the puncture site, but not with patient itself.Upon further review of the device, it was noted that the distal edged of the sheath was curled irregularly and did not display a smooth transition to the dilator.However, no adverse effects to the patient have been reported as a result of this product problem.

• 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: 6570452
• Report Number: 1820334-2017-01150
• Device Sequence Number: 10896036
• Product Code: DYB
• UDI-Device Identifier: 00827002562264
• UDI-Public: (01)00827002562264(17)180922(10)6224506
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

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-6.0-35-70-RB-HFANL1-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: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1