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

Model Number N/A

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)

Patient Problem Pneumothorax (2012)

Event Date 11/12/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery, lje catheter, nephrostomy d2b - procode: additional product codes: gbo, lje e1: uknown representative from humber river regional hospital, 200 church street, weston, ontario, ca m9n1n8 g4 ¿ 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.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 or that a death or serious injury occurred; nor is it admission 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

It was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter separated at the hub.The device was placed to treat a pneumothorax and was secured with suture.Later, on (b)(6) 2023, separation of the catheter was discovered by a nurse.As a result, the pneumothorax increased in size, and an additional procedure was required to replace the catheter.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.E3: inventory coordinator.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 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 or that a death or serious injury occurred; nor is it admission 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

Additional information was received.The mac-loc hub was attached to a vinyl connecting tube, part of which remained attached to the mac-loc.It is unknown if any force was exerted on the catheter.The patient's activity level was described as bed-ridden.The device was placed on (b)(6) 2023 and the failure occurred on (b)(6) 2023.Hospitalization was prolonged as the pneumothorax increased in size.

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.Correction: h6 (annex a, annex g) investigation ¿ evaluation it was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter separated at the hub.The device was placed on (b)(6) 2023 to treat a pneumothorax.The catheter was secured with suture, and the mac-loc hub was attached to a vinyl connecting tube.Later, on (b)(6) 2023, separation of the catheter was discovered by a nurse.It is unknown if any force was exerted on the catheter.The patient's activity level was described as bed ridden.As a result, the pneumothorax increased in size, an additional procedure was required to replace the catheter, and hospitalization was prolonged.As reported, the patient was female with dementia, and she was bed ridden.No other patient details were provided.No details regarding the placement procedure were provided.No other adverse effects were reported for this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.The ultrathane mac-loc locking loop multipurpose drainage catheter was returned in a used and damaged condition.The investigation confirmed that the 8.5 mac-loc adaptor was received separated from the catheter shaft.A visual examination discovered that a tear was present at the top portion of the flare.Additionally, thread marks were also present within the flare, near the top.Based on the on the evidence displayed regarding the flare, it is feasible to suggest the flare was too large, thus preventing proper seating between the cap and mac-loc adaptor.The device was determined to be out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots did not identify any other events associated with the reported device lot.A complaint history search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field cook also reviewed product labeling.The current instructions for use [ifu__multi2_rev1] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: precautions: patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a manufacturing deficiency at the supplier contributed to this incident.However, this is believed to be an isolated incident and there is no evidence of additional nonconforming devices in house or in the field.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE 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: 18275053
• MDR Text Key: 329840598
• Report Number: 1820334-2023-01640
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

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: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 15554006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/06/2023; 03/06/2024
• Supplement Dates FDA Received: 12/14/2023; 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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
• Patient Sex: Female