MAUDE Adverse Event Report: COOK INC ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Catalog Number ULT10.2-38-40-P-CLBS-26-RH

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 09/16/2016

Event Type  Injury  

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 that dr.(b)(6) had three cases in the passed two weeks in which the wire and stiffener were stuck inside the drainage catheter.The most recent case added an additional hour to their procedure and anesthesia time.

• Brand Name: ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• 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: 7034995
• MDR Text Key: 92143562
• Report Number: 1820334-2017-04095
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002133532
• UDI-Public: (01)00827002133532(17)190617(10)7052090
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULT10.2-38-40-P-CLBS-26-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70
• Patient Weight: 73