MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

(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 an ultrathane mac-loc locking loop biliary drainage catheter was selected for a biliary drainage procedure.While attempting to place the catheter, the catheter could not be separated from the cannula.The catheter was pulled back out and checked to ensure the cannula could be removed (was done but per the customer, not easily).Another attempt was made to place the catheter but the catheter and cannula could not be separated again.The catheter was then removed and found to be stuck on the cannula.Another drain was placed to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Although requested, patient weight and pre-existing conditions were not provided by the customer.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The inspection of the returned device confirmed that the cannula was stuck in the catheter, and was only able to be removed by holding the tip of the catheter and pulling on the hub of the cannula.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 showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints 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 established.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.

Event Description

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

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8052874
• MDR Text Key: 126658389
• Report Number: 1820334-2018-03318
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)210912(10)9157809
• 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: 01/24/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9157809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR