MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

While placing a neph-u catheter and experienced leaking from the same juncture point, where the soft catheter part joins with the hard locking hub part.After successful placement of catheter, it was noted that catheter was leaking where the soft part of the catheter connects to the hard part of the locking hub area.It was decided that the best course of action was to replace the catheter while the patient was still on the procedure table.The patient required no additional procedures.The product only caused additional time to the procedures in so much as it had to be exchanged for a like device.No adverse effects have been reported.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and trends of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the health risk assessment, no further action is required.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6093621
• MDR Text Key: 59621291
• Report Number: 1820334-2016-01269
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• 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: 62 YR
• Patient Weight: 49