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

Catalog Number ULT8.5-38-40-P-32S-CLB-RH

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: preamendment.(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 when placing a percutaneous biliary drain into the liver using an ultrathane mac-loc locking loop biliary drainage catheter, the drain seemed stuck on the stylet.It was described as a harmonica effect where the tip of the drain became stuck on the stylet.To date, additional patient and event information have not been made available.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional information received identified that per the customer, "when the drain over the guidewire was increased, it was rolled up.A 0.35 glidewire from terumo was used.This can sometimes give friction by friction when increasing material, but on second attempt with the same thread, but new biliary catheter (same size), this worked." it was also reported regarding anatomy and scar tissue, "calcification: n.V.T.Serpentine: not unlike biliary tract anatomy can be expected"."no scar tissue." additionally, it was clarified that the procedure took place (b)(6) 2018 and regarding action taken after experiencing this issue, "retrieved over guidewires, checked whether they were sitting on metal stretcher, trying to bring in a little bit and slower.Eventually new drain packed, which ran without problems." investigation ¿ evaluation: a review of the complaint history, device history record, documentation, and visual inspection/dimensional verification of the device was conducted during the investigation.The device was returned, however, the returned catheter was cut twice and in three separate pieces.Due to this, functional testing was not possible and the complaint has been confirmed due to customer testimony.All possible measurements were within specifications therefore unlikely for any non-conforming devices to be out in the field.Additionally, a document based evaluation was conducted.A review of the final device history record, did not identify any nonconformances related to the reported failure mode.Additionally, a search of the manufacturer's database identified this complaint to be the only one associated with lot number 8475268.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7440491
• MDR Text Key: 106191977
• Report Number: 1820334-2018-01001
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)201228(10)8475268
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2017
• 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