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

Catalog Number	KCFW-5.5-35-40-RB-BLKN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
During an unknown procedure, access was gained from the right femoral artery in order to advance the device to the lesion contralaterally.After experiencing strong resistance when advancing the device over a placed wire guide, the user checked the device and found that the device tip was "damaged" (curled up).Upon further review of the device, it was confirmed that the sheath tubing was curled at the transition to the dilator.Another manufacturer's device was used to complete the procedure and there was no report of adverse effects to the patient.

• Brand Name: FLEXOR BALKIN GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6569475
• Report Number: 1820334-2017-01151
• Device Sequence Number: 16171905
• Product Code: DYB
• UDI-Device Identifier: 00827002108820
• UDI-Public: (01)00827002108820(17)170401(10)4918767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• 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-5.5-35-40-RB-BLKN
• 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