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 Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: not exempt, 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 originally reported that an ultrathane mac-loc locking loop biliary drainage catheter was used during an unknown procedure.It was noted that the catheter appeared to be locked at the hub, but the pigtail loop became undone and unlocked.On 03aug2018, upon preliminary investigation of the returned device, it was found that the blue flexible stiffening cannula within the lumen of the catheter had instead become elongated and separated.No additional information about the event details or patient outcomes have been provided.

Event Description

In additional information received on 02oct2018, the physician clarified that the problem with the device was not a locking issue.After placing the device across the obstruction, the flexible stiffener was not able to be removed from the catheter.When the physician attempted to forcefully remove the stiffener, it broke apart in the catheter.A fragment of the stiffener remained inside the catheter.No unintended section of the device remained inside the patient's body.The complaint device was removed and replaced with a another drainage catheter that "locked properly".No adverse event was reported as a result of this event.

Manufacturer Narrative

Investigation /evaluation: a review of the device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device were conducted during the investigation.One 8.5fr mac-loc catheter was returned in a used and damaged condition with a piece of the flexible stiffener extending from the proximal hub.The other piece of the flexible stiffener that was returned was found to be separated and kinked.Locking and unlocking the device was done with difficulty.In an attempt to tighten the suture and close the pigtail, it was noted that the suture string at the distal end did not tighten and the tube began to accordion.Resistance was experienced when attempting to remove the flexible stiffener from the catheter lumen.When the fragment of the flexible stiffener was removed from the catheter, it was found to be kinked and elongated.After removal of the stiffener, the pigtail curl could be tightened and locked.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.Inspection activities are in place to prevent the release of nonconforming product related to the reported failure.A review of the device history record showed no nonconforming events that could be attributed to this failure mode.It should be noted that there were no other complaints for this lot number.The instructions for use included with the device includes images depicting the process of inserting and removing the stiffener, as well as locking and unlocking the mac-loc.The instructions for use states that, "multipurpose drainage catheters are intended for percutaneous drainage in a variety of drainage applications (e.G., nephrostomy, biliary and abscess), either by direct stick or seldinger access technique." "when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture." "these products are intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of percutaneous drainage catheters should be employed." "for locking loop catheters, lock the catheter in place using appropriate technique for the locking mechanism type, as described below.Stabilize the mac-lo catheter hub assembly with one hand and pull back on the drawstring to form the distal catheter loop configuration.While maintaining traction on the drawstring, push the locking cam lever down until a distinct "snap" is felt.The distal lop of the catheter is now locked into position.Trim off the excess drawstring." based on the information provided, examination of the returned product, and the results of our investigation, it was determined that the cause cannot be traced to the device.Possible contributing factors include tortuous patient anatomy, user technique and manufacturing error although the later is less likely as the measurements from the returned device investigation were all within the manufacturing specifications.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7801856
• MDR Text Key: 117839034
• Report Number: 1820334-2018-02535
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)201017(10)8299397
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2020
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 8299397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1