MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Common device name: specific device information is unavailable.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a catheter from an ultrathane cope nephroureterectomy set was used for an unspecified procedure.One week after placement, the hub detached from the device.The device was then exchanged.As reported, the patient did not experience any other adverse effects due to this incident.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, drawings, manufacturing instructions, quality control instructions and documentation was conducted during the investigation.The complaint device was not returned to aid in the investigation.A complete a review of the device history record (dhr) due to lack of lot information from the user facility.The complaint catalog number and lot information were not provided to aid in the investigation.As such, there is no evidence to suggest that non-conforming device lots exist in house or in the field.A review of current documentation was conducted and it was determined that inspection activities are in place to prevent the release of non-conforming product related to the reported failure mode.As a result of the investigation and all available information, a root cause for this failure could not be established.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.

Event Description

No additional information has been added to the event description since the previous medwatch report was submitted.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8219304
• MDR Text Key: 132194263
• Report Number: 1820334-2019-00010
• Device Sequence Number: 1
• Product Code: LJE
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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