MAUDE Adverse Event Report: COOK INC PEEL-AWAY INTRODUCER SHEATH SET; DYB INTRODUCER, CATHETER

Catalog Number C-PLI-9.0-38-X-1

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2017

Event Type  malfunction  

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 Description

It was reported the wire guide became stuck inside of the needle.Subsequently, the wire guide became elongated/unlabeled/separated when it was removed.As a result, the wire guide was removed from the patient.Another wire guide (0.035 inch) was used with the same needle to complete the procedure.

• Brand Name: PEEL-AWAY INTRODUCER SHEATH SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6931787
• MDR Text Key: 90301723
• Report Number: 1820334-2017-03377
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002070431
• UDI-Public: (01)00827002070431(17)191010(10)7347227
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-PLI-9.0-38-X-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1