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 Difficult to Remove (1528)

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

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Initial reporter also sent report to fda: unknown.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, an unknown patient required the placement of an ultrathane mac-loc locking loop biliary drainage catheter for a biliary system catheter exchange.The operator reported that "the catheter did not deploy correctly.The inner stylet was getting stuck." the operator was unable to remove the flexible stiffener.This failure was experienced on two catheters of the same lot.As reported, "one stylet broke in the catheter." a similar device from an different lot number was utilized to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 24feb2020.It was originally reported to cook that the flexible stiffener within two ultrathane mac-loc locking loop biliary drainage catheters could not be removed from the catheter.This incident was reported by (b)(6), in the united states.On 24feb2020, three devices were returned by the customer and it was presumed that the third device was an opened, but unused, device that was being returned to aid in the investigation.However, due to the presence of biomatter and further communication with the cook representative who returned the device, it was concluded by the investigation of this event that 3 devices were used on the patient and experienced difficulty removing the stiffener from the catheter.The failed devices was removed, and another was placed to successfully complete the procedure.No adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned three catheters to cook for investigation.For catheter 1, the flexible stiffener could not be flushed or removed from the catheter.The catheter/stiffener combination was soaked in warm water and the stiffener was able to be removed.The stiffener was occluded, kinked, and elongated.The catheter was able to be flushed, and slight biomatter was found but no occlusions.For catheter 2, the catheter was flushed and no occlusions were found.The flexible stiffener had multiple kinks noted on the device.For catheter 3, the catheter was able to be flushed with the stiffener segment lodged inside.Slight biomatter was found but no occlusions.No visible damage to the catheter was noted.The catheter was cut on the side and the separated section of stiffener was able to be removed.The stiffener¿s proximal end up to the point of separation was elongation with slight shedding.All dimensions deemed relevant to the reported failure mode were analyzed, and cook has concluded that the devices were manufactured to specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) was reviewed.The reported final lot and subassemblies were reviewed and revealed no relevant nonconformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Currently, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not upset he product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ it is possible that the sutures weren¿t taught while advancing the stiffeners, causing difficult removal, but at this time this cannot be confirmed.Based on information provided, inspection of returned product, and results of investigation, it was concluded that a component failure without manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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: 9636832
• MDR Text Key: 177369102
• Report Number: 1820334-2020-00219
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)220830(10)9983647
• 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,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: 9983647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1