MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Additional product codes: lje, gbo customer person: phone: country: (b)(6) postal code: (b)(6).Pma/510(k) #: k173035.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 that an ultrathane mac-loc locking loop biliary drainage catheter leaked at the hub.The device was required by an unknown patient for a standard drainage catheter exchange procedure.The device was placed and the patient was discharged.Later that day, the patient called to report leaking at the mac-loc hub.The patient immediately returned to the facility and the catheter was successfully replaced with a new like device.No further leaking was noted.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

In additional information received on 13oct2021, it was reported that the suture string was not tied around the locking lever.Leakage from the catheter tubing was not observed.The leak was from the hub.

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.

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) , a representative at the (b)(6) facility, located in the city of (b)(6), reported the following: the patient came in for standard change of drainage.The patient was discharged but called during the same day and reported that the locking hub to the ult10.2-38-40-p-32s-clb-rh was leaking.The patient came back for immediate drain exchange.A new drainage catheter, having the same lot number as above, was placed and no leaking was discovered.A review of the complaint history, device history record, quality control, and specifications of the device, as well as a visual inspection and functional test, were conducted during the investigation.The ult10.2-38-40-p-32s-clb-rh, ultrathane mac-loc locking loop biliary drainage catheter, lot number consisting of 14024708 was returned in a used and altered condition.During tabletop testing using a syringe and water, the catheter was discovered to be leaking at the site where the catheter and mac-loc adaptor are connected.Upon the disassembling of the cap from the mac-loc adaptor, it was discovered the flare was within the threads of the cap.The device was 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.Cook reviewed all associated device history records, confirming there were no relevant recorded non-conformances.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in the field.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, inspection of returned product and the results of the investigation, it was concluded the cause of this event is traced to component failure.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.

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: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12482814
• MDR Text Key: 271752621
• Report Number: 1820334-2021-02163
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 00827002094987
• UDI-Public: (01)00827002094987(17)240614(10)14024708
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: 14024708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 10/13/2021; 12/13/2021
• Supplement Dates FDA Received: 10/13/2021; 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention