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 Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

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 drainage procedure.The operator reported utilizing a neff access set and performing a right sided percutaneous transhepatic cholangiography, placing the drainage catheter over a guidewire.After inserting, it was reported they were unable to retrieve the metal stiffener and "bunching up" of the catheter was noted.The drain was removed from the patient and the procedure was completed successfully utilizing a competitors drainage tube.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

D10: product received on: 21feb2020.Investigation/evaluation: (b)(6) hospital informed cook of an incident involving a ultrathane mac-loc locking loop biliary drainage catheter.During a procedure there was difficulty removing the metal stiffener from the catheter.The catheter bunched up while removing the metal stiffener.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.This occurred during the procedure and another catheter was deployed to complete the procedure.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.One ult8.5 mac-loc was returned with the metal stiffener inserted through the catheter.The device is used with biomatter present.The metal stiffener was exiting the end of the catheter.An attempt to remove the stiffener was unsuccessful.The catheter was manipulated and was loosened from the stiffener.The stiffener was then able to be removed.The catheter tip is split.There is a bend in the stiffener starting at 48.8cm from the cap.The catheter inner diameter and metal stiffener length were measured to be within specification.Additionally, a document-based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The ifu supplied with mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.The device history record (dhr) was reviewed.The dhr for the final lot as well as sub-assembly lot revealed one related nonconformance.The nonconformance is for ¿endhole, incorrect or damaged." this affected a quantity of 5 that were scrapped prior to release.A complaint database search was completed on the lot and no additional complaints were found.As there are adequate inspection activities established, objective evidence that the dhr was fully executed and no additional complaints from the same lot, it was concluded that there is no evidence that nonconforming product exists in house or in field.Based on the information provided, visual inspection of the returned product, and results of the investigation, a definitive root cause could not be established.However, a capa is currently open to address metal stiffener advancement and removal difficulty.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.

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 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: 9732584
• MDR Text Key: 184738501
• Report Number: 1820334-2020-00407
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)211109(10)9301274
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9301274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 04/28/2020
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE