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 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: terumo surflo needle, terumo radifocus wire guide, cook aes wire guide.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

It was reported a ultrathane mac-loc locking loop biliary drainage catheter was used in an unknown patient during a percutaneous transhepatic cholangiogram drainage procedure.A competitors needle and another manufacturer wire guide were used to gain access.A competitors wire guide was then exchanged with a cook aes wire guide ¿to make the stiffening cannula tougher.¿ the operator advanced the drainage catheter with the stiffening cannula over the aes wire guide and reached the target site.The wire guide was then removed.It was reported that when trying to remove the stiffening cannula from the catheter, the physician felt resistance and despite ¿pulling the stiffening cannula a little stronger,¿ it could not be removed.It was then reported that the physician attempted to reinsert the aes wire guide into the cannula to help with removal, but the wire guide would could not be inserted into the cannula.Furthermore, the report stated, ¿the possibility that the inner lumen of the stiffening cannula got smashed was considered.¿ the drainage catheter was then cut at the shaft and the string was removed.The stiffening cannula still could not be removed from the catheter, so all the devices used for the procedure were removed from the patient¿s body and the procedure was not completed.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

D10: product received on: 16jul2019.Investigation/evaluation: 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 complaint device was returned to cook for investigation.During investigation, the flexible stiffener was lodged within the catheter, but after removing the suture, the stiffener was able to be removed without resistance.All dimensions deemed relevant to the reported failure mode were analyzed and found that the device was manufactured within specification.A document based investigation evaluation was also performed.Cook reviewed the design history file (dhf) for the affected product, and found that the product met all acceptance criterion during design verification testing for the reported failure mode.The device history record (dhr) for the reported lot and all relevant subassemblies and raw materials was reviewed and found one relevant nonconformance for tip damage.All nonconforming devices were scrapped and all products go through a 100% inspection for this nonconformance.A search of current complaint software revealed no additional complaints from the field.From this information, there is no evidence of nonconforming product from this lot in the field or in house.Based on the information provided, the examination of returned product, and the results of the investigation, the root cause was determined to be component failure without manufacturing or design defect.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.

• 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: 8789538
• MDR Text Key: 151125176
• Report Number: 1820334-2019-01687
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220226(10)9551170
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

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: 02/26/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9551170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1