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
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
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 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
• Common Device Name: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7034995
• Report Number: 1820334-2017-04095
• Device Sequence Number: 1915903
• Product Code: GCA
• UDI-Device Identifier: 00827002133532
• UDI-Public: (01)00827002133532(17)190617(10)7052090
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ULT10.2-38-40-P-CLBS-26-RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70
• Patient Weight: 73