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 04/04/2019

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 a ultrathane mac-loc locking loop biliary drainage catheter was used in an unknown patient for a drainage procedure.As reported, ¿it was impossible to remove the blue part of the drain (stiffening cannula).They used a new drain." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Concomitant medical products: product received on: 18jun2019.A review of the complaint history, device history record, 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.From the investigation, the flexible stiffener was able to be removed from the catheter with minimal force.While inspecting the flexible stiffener, multiple kinks along the shaft were noted.All dimensions deemed relevant to the reported failure mode were analyzed and found that the device was manufactured within specification.Due to the device not being manufactured out of specification, there is no evidence to suggest the issue is manufacturing related.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for this complaint lot and sub-assembly lots found one non-conformance relevant to the reported failure mode: lumen obstructed on the tubing sub-assembly.The nonconforming product was scrapped.A search for all additional sub assembly lots produced by the same operator on the same day was conducted and found that no additional lots had relevant nonconformances.Due to the lumen of the catheter tubing going through a 100% inspection for occlusions, and no additional nonconforming product being recorded for any additional lots produced by the same operator on the same day, it can be concluded that there is no additional nonconforming product from the reported lot or related lots in house.A software search for complaints on the reported lot and related lots was conducted and found no additional complaints from the field.Thus, there is no evidence suggesting that there is additional nonconforming product from the reported lot or related lots in the field.Based on the information provided, inspection of returned product, and the results of the investigation, cook has concluded a component failure without design or manufacturing issue contributed to this event.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: 8562291
• MDR Text Key: 144153985
• Report Number: 1820334-2019-00999
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220211(10)9510476
• 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: 06/27/2019

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: 02/11/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9510476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1