MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: exempt.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 "several" ultrathane mac-loc locking loop multipurpose drainage catheters experienced difficulty with their stiffeners.The catheters were introduced into the patients using either the flexible or metal stiffener without difficulty.However, when the operator tried to remove the stiffener, resistance was encountered and the catheter "wrinkled." the device was then removed and a different catheter was used to complete the procedures.As reported, the patient's did not experience any adverse effects or require additional procedures as a result of these occurrences.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A representative from(b)(6) in spain informed cook on (b)(6) 2021 of multiple incidents involving ultrathane mac-loc locking loop multipurpose drainage catheters.The dates of the events are unknown, and all incidents occurred during drainage procedures.For all incidents, the catheter was introduced with either the flexible or metal stiffener.There was resistance upon removal of the stiffeners that resulted in the catheter wrinkling.This made the procedure difficult and sometimes a new catheter was used to complete the procedure.The only adverse effects this had to the patients was making the procedure longer.A review of the instructions for use (ifu), drawing, manufacturing instructions (mi), quality control, and specifications of the device was conducted during the investigation.A complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) and the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.Based on the available information, cook has concluded that the devices were manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu 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.¿ instructions for use: ¿under fluoroscopic control, perform standard techniques for placement of percutaneous draining 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 for its configuration.¿ 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 use the 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.¿ a capa was previously opened to address difficulty advancing/removing flexible stiffeners and concluded that the inner diameter of the catheter was undersized due to a lack of in-process inspection diameters and material shrinkage.An additional capa was opened to address the issue of difficulty inserting/removing metal stiffeners.The capa addressing the metal stiffener concluded with manufacturing deficiencies.As the lot number is unknown, it cannot be determined if the devices were manufactured prior to or following correction implementation.Therefore, based on the information provided, no product returned, and the results of our investigation, a potential root cause for this event has been concluded to a manufacturing/quality control deficiency.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.

Event Description

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

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11252458
• MDR Text Key: 258842957
• Report Number: 1820334-2021-00204
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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 Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 01/29/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1