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

Catalog Number	KSAW-6.0-18/38-90-RB-ANL1-HC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2016
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 complaint device was used to treat the lesion in proximal part of left superficial femoral artery (sfa).The angle of the iliac bifurcation was severe.The right femoral artery was punctured and ansel sheath was advanced by contralateral approach.However, the sheath would not pass through the aortic bifurcation.Thus, the physician gave up contralateral approach with ansel sheath, and the procedure was completed by ipsilateral approach with another manufacturer's sheath.There were no reported adverse consequences to the patient.It was of the physicians opinion that cause of the event was the severe angle of the bifurcation and calcification in the access route and inflexibility of the artery.Per images of the returned product the sheath tip was stretched.

• 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: 6572055
• Report Number: 1820334-2017-01113
• Device Sequence Number: 749237
• Product Code: DYB
• UDI-Device Identifier: 00827002300033
• UDI-Public: (01)00827002300033(17)190926(10)7303632
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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-6.0-18/38-90-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: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1