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 Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation:occupation: radiology technician.Pma/510k: 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 an ultrathane mac-loc locking loop multipurpose drainage catheter leaked during use from under the mac loc lever.Additional information regarding the event and patient outcome has been requested but is currently unavailable.No other adverse effects were reported for this incident.

Event Description

Additional information was received 26jul2022.During a nephrostomy, an access set was utilized to place a drainage catheter.It was connected to a drainage bag and maintained by the facility's standard post procedure protocol.The fitting connection was securely attached and inspected.No force was exerted on the catheter.After a non-specific number of days, a leak was noted at the locking lever of the catheter.The patient required a device exchange in an additional procedure as a result of the leak.The patient did not have a prolonged hospital stay due to the occurrence, and no other adverse events were reported.

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

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.Investigation ¿ evaluation: on 08jul2022, a representative at the munson medical center, traverse mi, reported three separate events, involving three patients that required replacement of ultrathane mac-loc locking loop multipurpose drainage catheters (rpn: ult8.5-38-25-p-6s-clm-rh; lot unknown) due to leakage from under the mac-loc lever.This file captures the second patient.During a nephrostomy, an access set was utilized to place a drainage catheter.It was connected to a drainage bag and maintained by the facility's standard post procedure protocol.The fitting connection was securely attached and inspected.No force was exerted on the catheter.After a non-specific number of days, a leak was noted at the locking lever of the catheter.The patient required a device exchange in an additional procedure as a result of the leak.No other adverse events for the patient were reported.The other patients/events are captured in medwatch report reference numbers 1820334-2022-01262 and 1820334-2022-01264.Reviews of the instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide a lot number for this device.Therefore, cook medical inc.Performed an expanded sales search for the reported device, and was unable to identify the complaint lot.As a result, cook medical inc.Was unable to review the device history record.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.Since the lot number was not provided, the most recent instructions for use (ifu) t_multi2_rev1, ultrathane mac-loc locking loop multipurpose drainage catheter, provided with the suspect rpn were reviewed for the information related to reported failure mode.How supplied: "upon removal from package, inspect the product to ensure no damage has occurred." precautions ¿for best results, keep catheter surface wet during placement¿.Based on the information provided, no returned device, and the results of the investigation, it was determined the cause of this event is related to component failure.A definitive conclusion could not be determined why fluid was escaping from the beneath the locking lever of the mac-loc adaptor.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.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: 15088880
• MDR Text Key: 304230097
• Report Number: 1820334-2022-01263
• 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,Followup
• Report Date: 12/20/2022

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/26/2022; 11/29/2022
• Supplement Dates FDA Received: 08/02/2022; 12/20/2022
• 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
• Treatment: ACCESS SET; URINE DRAINAGE BAG
• Patient Outcome(s): Required Intervention