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 Problem Detachment of Device or Device Component (2907)

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

Event Date 03/14/2023

Event Type  Injury  

Event Description

It was reported that one month after placement of an ultrathane mac-loc locking loop multipurpose drainage catheter for drainage, a male patient returned to the hospital with the hub detached from the catheter.It was indicated that an additional procedure was required; however, the details of that procedure have not been provided.No other harm to the patient has been reported.Additional information regarding event details has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.

Manufacturer Narrative

Investigation - evaluation: it was reported by hospital (b)(6) that on (b)(6) 2023 an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot#: unknown) separated.The device was placed via micropuncture in a male patient¿s kidney for a nephrostomy drain.The device was securely attached to a bag for urine collection.About a month after placement, the patient returned to the facility with a damaged catheter.It was noted that the mac-loc had detached from the catheter.As result, the patient required an additional procedure to replace the catheter.No other adverse effects were reported due to this occurrence.Reviews of documentation including the complaint history, instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned complaint device, were conducted during the investigation.One used, damaged catheter was returned to cook for evaluation.The mac-loc adaptor was not returned.Upon visual examination of the ult8.5fr catheter, a tear in the bell of the flare was discovered.This most likely occurred from the mac-loc adaptor encountering excessive force, resulting in the separation of the two components.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.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 product labeling.The ifu (t_multi2_rev1, ultrathane mac-loc locking loop biliary drainage catheter) packaged with the device referenced instructing the product to be inspected prior to use to ensure no damage has occurred in relation to the reported failure mode.Based on the dmr, ifu and device evaluation, 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, inspection of the returned device, and the results of the investigation, cook concluded that patient activity likely contributed to the separation.The user did not identify any damage during initial placement.It is possible that the catheter underwent excessive force or tension, due to the patient having free mobility at his residence.There is no evidence of manufacturing deficiency.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.

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.

Event Description

In additional information received on 09apr2023, it was reported that the device was placed in the kidney via micropuncture with a cook neff percutaneous access set during a nephrostomy procedure.The device was placed for urine drainage.No resistance was experienced during insertion or removal of any device components.Upon first inspection, the fitting was found to be securely attached.One month after placement, the hub detached from the catheter.The patient required an additional procedure to remove and replace the complaint device.The patient's activity level was described a "free moving." a bag was connected to the device at the time of failure.It was noted that no force was exerted on the catheter at any time.The patient did not experience any additional adverse effects due to this occurrence.

• 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: 16645518
• MDR Text Key: 312342981
• Report Number: 1820334-2023-00351
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

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: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 04/09/2023; 05/31/2023
• Supplement Dates FDA Received: 04/12/2023; 06/14/2023
• 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
• Treatment: NEFF PERCUTANEOUS ACCESS SET
• Patient Outcome(s): Required Intervention
• Patient Sex: Male