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); Fitting Problem (2183); Separation Problem (4043)

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

Event Date 02/17/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation- occupation: program manager.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

It was reported that an unknown patient required replacement of an ultrathane mac-loc locking loop multipurpose drainage catheter.The patient had the ultrathane mac-loc locking loop multipurpose drainage catheter placed on (b)(6) 2023 for nephrostomy drainage.On the same day, after the drain was placed, the patient fell while on the covid unit.Though the patient denies the tube being pulled, it was said that there is a possibility.The catheter tube separated from the white connector/hub, causing leaking.The drainage catheter was replaced and the patient's discharge was delayed by one overnight stay.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation it was reported by a representative of university of texas md anderson cancer center that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-6s-clm-rh; lot#: unknown) separated.The device was required for use as a nephrostomy drain and was placed in the patient on (b)(6) 2023.Later that day, the patient experienced a fall, and separation between the mac-loc cap and catheter shaft was observed (photo provided).The patient denied that the catheter was pulled.As a result of this event, the patient was hospitalized for an additional day, and the catheter was removed and replaced.No other adverse effects were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), quality control procedures, and specifications of the device, as well as visual inspection of the customer provided photo, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a photo was provided showing the reported hub separation from catheter.Additionally, a document-based investigation evaluation was performed.Cook completed a review of the product device master record (dmr) and concluded that hat sufficient controls are in place to detect this failure mode prior to release.Since the customer did not provide a lot number, cook medical performed an expanded sales search for the reporting customer, from 21feb2019 up to 21feb2023 regarding the (ult10.2-38-25-p-6s-clm-rh, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter).Cook medical reviewed sales records and was unable to identify the complaint lot.As a result, cook medical inc.Was unable to review the device history record.Cook also reviewed product labeling.The ifu supplied (t_multi2_rev1, ultrathane mac-loc locking loop multipurpose drainage catheter) instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the dmr, ifu and provided photo, cook medical determined there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of provided photo, and the results of the investigation, cook medical has concluded that patient activity likely contributed to the reported issue.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.

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 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: 16457111
• MDR Text Key: 310406654
• Report Number: 1820334-2023-00194
• 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: 06/16/2023

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention