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 07/12/2019

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

It was reported an ultrathane mac-loc locking loop biliary drainage catheter was selected for percutaneous transhepatic drainage.During deployment, the metal stylet could not be removed from the catheter.The entire device was removed and replaced with another manufacturer's catheter.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: 23jul2019.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 metal stiffener was extending past the distal tip of the catheter, but was able to be removed without difficulty.All dimensions relevant to the reported failure were analyzed and found that the device was manufactured within specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) for this lot was reviewed and found no relevant nonconformances recorded for this failure.A software search for complaints on the reported lot found no additional complaints from the field.Due to this information, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.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 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: 8789563
• MDR Text Key: 151124541
• Report Number: 1820334-2019-01688
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)211101(10)9279852
• 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: 09/20/2019

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9279852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED GUIDE WIRE