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 Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: materials manager.Pma/510(k) #: pre-amendment.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 placed in an unknown patient for biliary drainage.During the procedure, the operator noticed leakage ¿between the proximal end of the catheter and the mac lock.¿ the defective device was removed and replaced by a device of the same lot and the same failure was noted.The procedure was successfully completed with a new, similar device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: d10, h3.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.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10- product received on: 14nov2019.H6- additional methods code: communication/interviews (4111).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 of unused product, were conducted during the investigation.The complainant did not return the two used devices, but returned six unopened devices from two separate lots for investigation.All six devices were leak tested.Of the six devices, three devices from the complaint lot failed the test and leaked at the cap-to-tubing interface.The three devices from another lot did not leak during the leak test.No further analysis was completed on the non-leaked devices, as no failure was detected.At this time, there is no evidence suggesting the non-leaking devices were manufactured out of specification.A tug/twist test was performed on the catheters that failed the leak test and determined the flares were securely seated within the hub.No other damage was noted to the devices.The distance between the cap and the hub was measured and determined to be 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.Based on the review of current documentation, cook has concluded that inspection activities are in place to prevent the release of non-conforming product related to the reported failure mode.The instructions for use (ifu) supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.The device history record (dhr) for the complaint lot and related subassembly lots was also reviewed.The dhr show no nonconformances.A database search there have been no additional complaints reported from the field for this lot.With 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, inspection of returned unused products and the results of the investigation, it was concluded that a manufacturing and quality control deficiency likely contributed to this incident.Corrective actions including implementation of a gap gauge and retraining were performed.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: 9266215
• MDR Text Key: 165026094
• Report Number: 1820334-2019-02749
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002289451
• UDI-Public: (01)00827002289451(17)220618(10)NS9820683
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-32S-CLB-RH
• Device Lot Number: NS9820683
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1