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

Catalog Number	KSAW-6.0-18/38-55-RB-ANL1-HC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2016
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
It was reported the physician attempted to advance the devices to superficial femoral artery (sfa) by contralateral aortic crossover approach.Although the physician tried to cross the aortic bifurcation with the combination of the flexor ansel guiding sheath and another manufacturer's wire guide.The flexor ansel guiding sheath would not advance smoothly, since the compatibility between the dilator (the one for 0.035inch) and wire guide was "so bad." another manufacturer's sheath was used without problems.It was reported there were no adverse effects to the patient as a result of the difficulties.Additionally, device imaging identified the tip of the dilator appears to have damage consistent with breakage and/ or peeling of the hydrophilic coating.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6567144
• Report Number: 1820334-2017-01184
• Device Sequence Number: 10928141
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)181207(10)6431926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• 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: KSAW-6.0-18/38-55-RB-ANL1-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
• Concomitant Medical Products and Therapy/Usage Dates: RADIFOCUST WIRE GUIDEDESTINATION SHEATH