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 Device Dislodged or Dislocated (2923)

Patient Problems Urinary Retention (2119); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2021

Event Type  Injury  

Manufacturer Narrative

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 a patient's ultrathane mac-loc locking loop multipurpose drainage catheter dislodged.The device was required for a study procedure (mdr-1919) for suprapubic urinary drainage and was placed on (b)(6) 2021.Dilation was performed prior to catheter placement, then the device was successfully placed via ultrasound guidance.Drainage was successfully established.On (b)(6) 2021, the device was accidentally dislodged.The next day, a new suprapubic catheter was successfully placed.No other adverse events were reported due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, b7, correction: h6 (annex e): 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

Additional information was provided on 22jun2022.Complete fluid evacuation was not achieved using this device as it was being used as a suprapubic catheter for urinary drainage.On (b)(6) 2021, 25 days post procedure, the patient accidentally dislodged the suprapubic catheter.Urinary retention occurred because the catheter had been dislodged.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: it was reported that a patient's ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult10.2-38-25-p-6s-clm-rh lot#: 13589750) dislodged.The device was required for a study procedure (mdr-1919) for suprapubic urinary drainage and was placed in the bladder on 13jan2021.Dilation was performed prior to catheter placement, then the device was successfully placed via ultrasound guidance.Drainage was successfully established.On 07feb2021, the device was accidentally dislodged and the patient experienced urine retention.The next day, a new suprapubic catheter was successfully placed.No other adverse events were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), quality control, and instructions for use (ifu) of the device, were conducted during the investigation.The complaint device was not returned to the manufacturer for evaluation; therefore, no physical examinations could be conducted.However, 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 dhr for the reported complaint device lot revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.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.The instructions for use (ifu) [ t_multi2_rev1, multipurpose drainage catheter] states the following.¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.Intended use: multiple drainage catheters are intended for percutaneous drainage applications (e.G nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.Warnings: if a catheter has become malposition or if drainage ceases, the catheter should be promptly exchanged or removed.References: these instructions for use are based on experience from physicians and (or) their published literature.Refer to your local cook sales representative for information on available literature.¿ based on the available information, no device return, and the results of the investigation, cook has concluded the cause of this event cannot be traced to the device.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: 14655131
• MDR Text Key: 294882981
• Report Number: 1820334-2022-01035
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095021
• UDI-Public: (01)00827002095021(17)231125(10)13589750
• 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,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2022

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 Expiration Date: 11/25/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-6S-CLM-RH
• Device Lot Number: 13589750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 11/29/2022
• Supplement Dates FDA Received: 06/29/2022; 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG