MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 03/28/2023

Event Type  Injury  

Event Description

It was reported the patient required replacement of an ultrathane mac-loc locking loop multipurpose drainage catheter.The catheter was placed in the patient for bilateral nephrostomy drainage.Two weeks after placement, the patient returned and leakage at the hub and lever area were noticed when the patient got on the table to have the catheter checked.It was also reported the mac-loc hub snapped off.The catheter was replaced due to potential for infection.The site noted this occurrence happened with multiple patients and at least 4 patients, including this incident, in the last month.The other 3 patient are documented under the patient identifier (b)(6).No other adverse effects were reported for this incident.

Manufacturer Narrative

D4 - lot #: remaining lot numbers at site are 15256682, 15210447, and 14915933.E3 - occupation: ir manager.G4 - pma/510(k) #: exempt.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.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by a (b)(6) hospital (usa) that two ultrathane mac-loc locking loop multipurpose drainage catheters (rpn: ult10.2-38-25-p-6s-clm-rh; lot#: unknown) leaked.The devices were placed in the patient on 06mar2023 for use as bilateral nephrostomy drainage catheters.On (b)(6) 2023, the patient returned to the facility due to leakage from hubs, near the locking levers.As a result, an additional procedure was required to remove and replace the devices.No other adverse events were reported due to this occurrence.The customer noted this occurrence happened with multiple patients and at least 4 patients, including this incident, in the last month.The other 3 patient are documented under the mdr # 1820334-2023-00500.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of the returned devices, were conducted during the investigation.The customer returned 7 of the 9 mentioned devices, having a product description consisting of ult10.2-38-25-p-6s-clm-rh,ultrathane mac-loc locking loop multipurpose drainage catheter, involving three lots, (15256682, 15210447 and 14915933).The two mentioned used devices were not returned, in addition to the customer not providing lot number information.The returned devices were received in an unopened condition.During table top testing, the devices were leaked tested, showing no fluid escaping from the proximal end.Additionally, each device passed the gap gauge requirement regarding the cap and adaptor connection site.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.Cook also reviewed the device history records from the 7 unopened devices, having product label lot information consisting of 15256682,15210447 and 14915933, confirming recorded nonconformances.Based on the nonconforming criteria, lot 14915933 had one relevant recorded nonconformance for "gap incorrect".This one device was scrapped prior to further processing.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [t_multi2_rev1] multipurpose drainage catheter, packaged with the device contains the following in relation to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned devices, and the results of the investigation, cook medical has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.However, a definitive conclusion could not be determined why fluid was escaping from the locking lever.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: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 16797898
• MDR Text Key: 313850951
• Report Number: 1820334-2023-00499
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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