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 Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2019

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 use in a percutaneous biliary drainage procedure.Prior to patient contact, air leakage was detected between the catheter and the mac-loc.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device did not make patient contact.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Investigation/evaluation: a review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications, as well as a visual inspection, dimensional verification and functional test of the returned device was conducted during the investigation.One catheter was returned for evaluation.Slight biological matter was observed throughout the device; however, no surface damage was noted.A tug and twist test of the tubing confirmed that the flare was secured within the cap.A leak test confirmed the presence of a leak at the cap-to-tubing interface.All dimensions deemed relevant to the failure mode were analyzed and found that the device was manufactured within specification.Additionally, a document-based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record found one relevant nonconformance for the complaint lot for an inadequate flare, in which one device was scrapped.Although this nonconformance is relevant to the reported failure mode, the reported product goes through a 100% inspection for the reported nonconformance, and all nonconforming product was scrapped.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified.We 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.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 8926855
• MDR Text Key: 175686647
• Report Number: 1820334-2019-02109
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220415(10)9668736
• 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,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9668736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO WIRE GUIDE