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 Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: 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 an unknown patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for a percutaneous biliary drainage procedure.After flushing of the catheter and the introducer, the operator noticed the introducer did not "advance fully" through the catheter.The operator noted "the introducer got stuck within the catheter." the device was replaced with another device of a different lot and a "similar situation" occurred.The second device was used to complete the procedure, but "with some difficulty".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The first device is recorded under the medwatch report with patient identifier (b)(6) (this report).The second device is recorded under the medwatch report with patient identifier (b)(6).

Event Description

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

Manufacturer Narrative

Concomitant medical product received on: 09dec2019.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 complainant returned one catheter and flexible stiffener for investigation.Physical examination of the returned device showed the flexible stiffener partially inserted in the catheter and biomatter present throughout the device.The flexible stiffener was able to be removed with some difficulty, and multiple kinks were noted on the flexible stiffener.No other damage was noted to either device.All dimensions relevant to the reported failure mode were analyzed and confirmed that the device was manufactured 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 device history record (dhr) for the complaint device lot and relevant subassemblies revealed two reported nonconformances relevant to the reported failure mode.However, all nonconforming products were scrapped, and the product goes through a 100% inspection for the reported nonconformance.A database search revealed no other complaints have been reported for the device lot.There is no evidence the device was not manufactured to specification or that there are nonconforming devices in house or out in the field.The device is shipped with instruction for use (ifu) which notes: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ based on the information provided, returned product and the results of the investigation, it was concluded that a component failure without a manufacturing or design defect contributed to the failure mode.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: 9374974
• MDR Text Key: 177165201
• Report Number: 1820334-2019-02952
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220826(10)9971671
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9971671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1