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

Model Number N/A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/25/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Initial reporter name and address: customer (person): (b)(6).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 ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter became difficult to remove from an unknown patient during a nephrostomy catheter exchange.The catheter was initially inserted on (b)(6) 2022 and the patient was to undergo a routine exchange on (b)(6) 2023.During the procedure, the physician experienced difficulty advancing the cook amplatz extra stiff wire guide through the drainage catheter.The wire was eventually able to advance towards the tip of the catheter; however, the pigtail would not straighten out.Despite several attempts to straighten the pigtail, the physician then cut the hub off of the catheter.It was noted that the pigtail remained locked.The physician felt there was no other option but to send the patient to have the device removed in the operating room under general anesthesia.The complaint device was then thrown away following removal.In addition, the patient was prescribed a precautionary week's supply of antibiotics.The physician confirmed that the patient was discharged, and no other adverse effects have been reported.Additional information regarding event details has been requested but is currently unavailable.

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 13mar2023, it was reported that the patient involved was an approximately 50-year-old female, with no other preexisting conditions noted apart from the urinary stone obstruction that led to requiring a nephrostomy.The device was placed in the upper left renal pelvis/lower back during a nephrostomy procedure for indication of obstructing urinary stones.Latex gloves were worn during insertion of catheter.The coating was activated by placing the device in a bowl of saline or being wiped/pressed with a piece of very wet sterile gauze soaked in saline, for an unknown amount of time.No issues were noted with the patient's anatomy or calcifications.No notes were made by surgeon/staff removing device regarding any encrustation on the removed catheter.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation a representative from derby hospitals nhs foundation trust (great britain) reported that on (b)(6) 2023 an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: (b)(4) ; lot#: 13901115) was difficult to remove.The device was required by a female patient in her 50s for use as a nephrostomy drain to treat obstruction related to kidney stones.On (b)(6) 2022, access was made via the patient¿s left lower back, and the device was placed in the upper left renal pelvis.It was noted that the hydrophilic coating was activated during the placement procedure.On (b)(6) 2023, a routine catheter replacement was attempted.During the replacement procedure, a cook amplatz extra stiff wire guide (rpn: (b)(4) ; lot: unknown) was inserted into the catheter; however, the pigtail would not release.After several attempts to straighten the pigtail, the mac-loc hub was cut but the pigtail still would not release.As a result, the patient was sent to the operating room (or) where the device was successfully removed under general anesthesia.Additionally, the patient was placed on prophylactic antibiotics for a week.No additional adverse events were reported due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures of the complaint 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.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot 13901115 and the related subassembly lots revealed two relevant non-conformances for "suture, routing incorrect" and string hole, damaged" each having a quantity of 1.These two devices were scrapped prior to further processing of the order.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot.Cook also reviewed product labeling.The product ifu, [t_multi_rev5 ¿multipurpose drainage catheter,¿ packaged with the device contains the following in relation to the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ instructions for use: ¿under fluoroscopic control, perform standard techniques for placement of percutaneous draining catheters, either by seldinger access or trocar access.-once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to for its configuration.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, ifu, and dhr 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, no product returned, and the results of the investigation, cook medical has concluded the root cause category would fall under cause traced to component failure without any design or manufacturing 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 DAWSON-MUELLER 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: 16497776
• MDR Text Key: 310823353
• Report Number: 1820334-2023-00232
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097056
• UDI-Public: (01)00827002097056(17)240419(10)13901115
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2023

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 Expiration Date: 04/19/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-HC
• Device Lot Number: 13901115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 03/13/2023; 05/31/2023
• Supplement Dates FDA Received: 03/13/2023; 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: COOK AMPLATZ EXTRA STIFF WIRE: THSF-35-80-AES.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female