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 Break (1069)

Patient Problem No Code Available (3191)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

International customer reported that a patient was undergoing placement of a ultrathane mac-loc locking loop biliary drainage catheter.The radiologist successfully inserted the drainage catheter.The radiologist was not able to remove the stylet upon insertion of the catheter.The stylet broke after several attempts at removal.The catheter was explanted and replaced with a new device.The actual device is not available for evaluation.There are no reports of any adverse patient consequences.

Manufacturer Narrative

Investigation - evaluation a review of dimensional verification, drawings, device history, complaint history, documentation, manufacturing instructions, instructions for use (ifu), specification, quality control (qc) data and visual inspection of the actual device was conducted during the investigation.A document review for the catheter and flexible stiffener was performed.In final device quality control, there is 100% verification that a flexible stiffener will pass freely through the catheter, proximal fittings, and lumen.The qc document specifies level 1 inspection of the size and surface roughness of the flexible stiffener.The product is supplied with an ifu which contains detailed instructions for use and precautions.This to be the only complaint associated with the main lot number and component lot numbers.The main work order and subassemblies were also reviewed for nonconformances.A review of the main work order confirmed no nonconformances during the manufacturing process.All nonconforming products were scrapped.The nonconformances for obstructed lumen/blocked lumen, difficult to wire/will not wire, and damaged tips may have been related to the failure mode but all the nonconformances were scrapped.A risk analysis for the multipurpose/biliary drainage catheters and sets, outlines potential failure modes, causes and effects for failure, and current risk controls in place to mitigate the occurrence of the potential risks.Inability to insert the flexible stiffener into the catheter was one potential failure mode.A device failure analysis was performed on the used device.The device was returned with the flexible stiffener completely inserted into the catheter to the distal tip and it could not be removed.The inner diameter of the catheter and outer diameter of the flexible stiffener were measured and compared to the specifications.During the failure analysis, the outer diameter of the flexible stiffener appeared to fail.However, only the proximal end of the flexible stiffener could be measured because the rest was stuck inside the catheter.In addition, the flexible stiffener may have not been perfectly circular in shape.Therefore, there is not enough evidence to suggest the flexible stiffener was manufactured out of specification.However, with all the potentially related nonconformances, the root cause may be manufacturing related.We will notify the appropriate personnel and 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6725625
• MDR Text Key: 80456946
• Report Number: 1820334-2017-01757
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)200414(10)7832637
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2017
• 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
• Patient Outcome(s): Required Intervention