MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH

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	08/05/2015
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
The device was used for percutaneous transluminal angioplasty (pta) in the left subclavian artery, inserted from the right common femoral artery (cfa), but it would not advance.The user removed the device once to check it and found that the tip was damaged.Then, dilation was performed with a 5fr sheath and another manufacturer's device was used instead.The physician commented the puncture site was a bit hard.Examination of the device revealed a small tear and stretching noticed at the tip.There have been no adverse effects to the patient reported.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6567871
• Report Number: 1820334-2017-01135
• Device Sequence Number: 91743
• Product Code: DQY
• UDI-Device Identifier: 00827002300033
• UDI-Public: (01)00827002300033(17)161001(10)F4600360
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• 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-6.0-18/38-90-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: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1