MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); No Code Available (3191)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: exempt.(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 patient with an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was hospitalized for a fever and left kidney infection.The catheter was placed around 4 weeks prior to the hospital visit.On (b)(6) 2018, the scheduled clinic appointment for a planned bag and dressing change, as well as possible flushing of the nephrostomy catheter, was cancelled.The next day, the patient visited the emergency room with 101.8 fever.The patient was then hospitalized and received intravenous (iv) antibiotics for left kidney infection.The nephrostomy tube was exchanged on (b)(6) 2018.The infection and nephrostomy catheter exchange is recorded under this medwatch report.Later on the same day of the exchange, the replacement nephrostomy catheter was confirmed to be leaking.The nephrostomy catheter was again replaced that night successfully.This exchange is recorded under medwatch report #1820334-2019-00087.The patient remained hospitalized for iv antibiotics until they were discharged on (b)(6) 2018.No other adverse effects were reported for this incident.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: investigation ¿ evaluation.A review of the complaint history, instructions for use (ifu), and quality control 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.The clinical assessment of the complaint found that there is no evidence to suggest a causal relationship between the nephrostomy tube and the kidney infection.Based on the information provided, no product returned and the results of the investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8254499
• MDR Text Key: 133314474
• Report Number: 1820334-2019-00062
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR