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

Catalog Number ULT10.2-38-40-P-32S-CLB-RH

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: pre-amendment.(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 during a percutaneous transhepatic biliary drainage (ptbd) in the chest, the ultrathane mac-loc locking loop biliary drainage catheter would not separate from the cannula.The device was removed.To date, additional patient and event information has not been provided.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Additional information: additional information received identified another device was successfully used to complete the procedure.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification, of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the stiffening cannula was difficult to remove.However, it cannot be determined with certainty why the stiffener was difficult to remove.Because the device failure analysis indicated the stiffening cannula was bowed upon withdrawal, it is reasonable to suggest that the bowed stiffening cannula made it difficult to remove.It is also reasonable to suggest that the inability to withdraw the cannula resulted in the cannula becoming bowed.It is also reasonable to suggest that the cannula became slightly bowed during shipping/handling.It cannot be confirmed which event regarding the bowing of the cannula occurred first, or whether it attributed to the reported failure.Also, biomatter present at end hold of catheter, therefore end hole diameter could not be measured.Catheter bisected in order to measure id.The device passed all dimensional testing.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 as the other complaint for this lot was created for non-reportable failure mode.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.This failure mode has been escalated per internal processes.We will continue to monitor for similar complaints and have notified the proper personnel about this event.Per the quality engineering risk assessment, no further action is required.

• 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: 7472947
• MDR Text Key: 107245286
• Report Number: 1820334-2018-01255
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)201108(10)8359348
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO WIRE GUIDE