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 Difficult to Remove (1528)

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

Event Date 02/02/2018

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It was reported during a pontine tegmental cap dysplasia procedure, the needle was unable to be withdrawn from the cannula working alongside an ultrathane mac-loc locking loop biliary drainage catheter.All devices were removed and another like set of devices were used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Corrected data: at the time of the initial mdr, the procedure was erroneously reported as pontine tegmental cap dysplasia procedure - this is a disease and not a procedure.There is no information in the complaint record relating this disease to the patient.The procedure at the time of the event was a percutaneous transhepatic cholangio-drainage procedure.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, specifications, and a visual inspection/ dimensional verification/functional test of the returned device were conducted during the investigation.Physical examination of the complaint device confirms we received one 8.5fr ult catheter with the metal stiffener inserted.Biomatter is present on the distal end of the device.The suture string appears to be present.Upon attempted removal of the metal stiffener, resistance was felt and the catheter tubing began to accordion.After removal, the distal portion of the stiffener is bowed.No other damage was observed.Catheter inner diameter, catheter outer diameter, stiffening cannula length from bottom of hub to distal end, stiffening cannula outer diameter, and catheter end hole diameter were all found to be within specification.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no notable gaps in production or processing controls were noted.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.Instructions for use state: catheter placement under fluoroscopic control, perform standard techniques for placement of percutaneous drainage catheters, either by seldinger access or trocar access.Once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration.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.Appropriate measures have been initiated to address this failure mode.We will continue to monitor for similar complaints.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: 7456348
• MDR Text Key: 106392528
• Report Number: 1820334-2018-01009
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)190111(10)6509984
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• 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
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CANNULA, UNSPECIFIED.NEEDLE, UNSPECIFIED.
• Patient Age: 73 YR
• Patient Weight: 48