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 Aspiration Issue (2883)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The event is currently under investigation.

Event Description

After placement of the catheter at desired lesion, the user attempted negative pressure with syringe to confirm location of the catheter, but only air was aspirated.The complaint catheter was removed from the patient's body, and another device was used instead.

Manufacturer Narrative

Labeling review: investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, trends, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.A leak test of the returned device was performed.The entire locking assembly was submerged in water and injected with air via 30cc syringe.There was a constant stream of air bubbles released between the cap and mac-loc connection as air was injected, thus confirming a leakage.The visual inspection of the device confirmed that the flare on the mac-loc assembly was slightly larger than the minor diameter of the internal cap threads.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record indicated that the lot met all finished goods release criteria.It should be noted there was one other reported complaint for this lot number.Based on the information provided, the examination of the returned product, 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 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
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5920625
• MDR Text Key: 53679815
• Report Number: 1820334-2016-00856
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002137660
• UDI-Public: (01)00827002137660(17)180715(10)6033401
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-WF-HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• 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