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

Catalog Number	KSAW-5.0-18/38-90-RB-SHTL-HC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2015
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
It was reported that during a procedure, when attempting to advance the sheath down into the left sfa, the dilator seemed to be getting hung in the aorta.Subsequently, the dilator was removed and the sheath was advanced without the dilator to complete the procedure.It was also reported that after the procedure, upon examining the dilator, the tip/taper of the dilator was noted to not "seem to be right" as per the customer, the tip was usually more of a point but the tip of this dilator was more uniformed.When a comparison was done between the.035 dilator and the.018 dilator, there was a difference in the tips.Visual inspection identified the.035 dilator taper was blunt and inadequate.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6567295
• Report Number: 1820334-2017-01102
• Device Sequence Number: 18867656
• Product Code: DYB
• UDI-Device Identifier: 00827002300095
• UDI-Public: (01)00827002300095(17)171028(10)5397251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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-5.0-18/38-90-RB-SHTL-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