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 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 an ultrathane mac-loc locking loop biliary drainage catheter for an unspecified indication.The customer reports that "the drain broke itself during the procedure." the break occurred at the "crossing of the tube and the maclock system." the device was explanted and exchanged with a new device during the initial implant procedure.The handling conditions and circumstances surrounding the event were not provided.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation a review of the complaint history, documentation, instructions for use (ifu), manufacturing instructions, quality control, dimensional verification, device history record, drawing, and visual inspection / functional testing of the returned device was conducted during the investigation.No issues were found related to the reported complaint.The catheter was returned with part of the tubing coming out of the cap, but not fully separated.Biomatter was present.The suture was cut.The cap would not untwist.No threads were present between the mac-loc and cap.The mac-loc was in the locked position.Upon closer inspection at 20x magnification, the tubing appeared to be ripped within the cap, which was what was coming out of the cap.The catheter tubing was measured to be within specification.The rest of the tubing could not be pulled out of the cap.The assembly of the mac-loc, cap, and tubing appeared to be secure, with the failure occurring only in the tubing.Review of the device history record of the finished product shows no nonconforming events that would contribute to the reported failure mode.There were no other reported complaints for this lot number.The risk specification for this product identifies the risk of separation of shaft from hub, which includes complete separation and leakage; it identifies that multiple risk controls are in place to mitigate the risk of this type of failure.There was no evidence to suggest that this device was made out of specification.The root cause could possibly be related to: 1) excessive force was put on the tubing during handling or the procedure, causing it to rip; 2) the tubing was damaged during assembly of the proximal assembly, causing a weakness in tubing leading to ripping during the procedure.However, the manufacturing process for proximal assembly is validated for tensile strength to mitigate some risk of the latter happening.The root cause was therefore identified as product use or handling with operational or environmental context as possible.The complaint will be confirmed based on returned device evaluation.Per the quality engineering risk assessment, no further action is warranted.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 ; 8128294891
• MDR Report Key: 6728075
• MDR Text Key: 80545951
• Report Number: 1820334-2017-01764
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002095007
• UDI-Public: (01)00827002095007(17)200314(10)7748328
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• 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: ULT14.0-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2017
• 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