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 Difficult to Remove (1528); Material Twisted/Bent (2981)

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported a patient required placement of an ultrathane mac-loc locking loop multipurpose drainage catheter.They stated that during placement "two drains broke in the patient", but they were able to successfully retrieve "all the pieces out of the patient." two used drainage catheters along with two blue flexible stiffeners were returned to cook on (b)(6) 2022.The first drainage catheter and flexible stiffener were intact but the stiffener was noted to have multiple kinks present, likely from difficulty removing the flexible stiffener.The second drainage catheter and flexible stiffener were returned separated.The shaft of the proximal end of the catheter was separated with the hub missing.The flexible stiffener was separated in 3 pieces and elongated with the hub missing.There was no retrieval required for the first device.For the second device, all device fragments were retrieved from the patient.The patient will require an additional procedure, but it is currently unknown if this has occurred.Additional information regarding the event and patient outcome has been requested but is currently unavailable.This report captures the first flexible stiffener that was returned with kinks present, likely from difficult removal of the stiffener.The second device that separated is captured under patient identifier (b)(6).

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

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

On 28jun2022, it was confirmed that both stiffeners got stuck in the drains and one stiffener ultimately separated in the tube.The procedure was a nephrostomy tube exchange through the ostomy.No medical intervention was required to retrieve the separated piece of stiffener.However, access through the ostomy was lost.The patient had a percutaneous nephrostomy placed until the patient could be brought back in to reestablish access into the ostomy in an additional procedure.It was also clarified that the catheter shaft separation noted upon device return was a result of cutting the catheter to ensure no portion of the device remained in the patient.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: on 03jun2022, cook medical inc.Received a complaint from a representative at the scott & white memorial hospital, located in the city of roundrock, tx.During an attempt to place an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-45-p-6s-clm-rh, lot: 14366975), difficulty was encountered when attempting to withdrawal the flexible stiffener.Ultimately, separation of the stiffener occurred.The catheter and flexible stiffener were both removed, confirming there was no material left within the patient.No medical intervention was required.The patient was brought back and had to have a percutaneous nephrostomy placed since access was lost through the ostomy.Following device placement, the patient was able to come back to re-establish access into the ostomy.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), drawing, manufacturing instructions, quality control procedures, and specifications, as well as a visual inspection, functional test and dimensional verification of the returned device, were conducted during the investigation.One ult8.5-38-45-p-6s-clm-rh catheter was returned in a used and damaged condition.It was confirmed during table-top testing that the stiffener was difficult to advance in the catheter.Using a tfe coated wire guide, advancement of the stiffener was successful.The stiffener was able to be removed from the catheter after the tfe coated wire was removed.Multiple kinks were present in the shaft at the blue stiffener near the proximal hub.The inner and outer diameter of the stiffener were measured and found to be within specification.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 ode prior to distribution.A review of the device history record (dhr) for lot 14366975 and subassembly lots found one nonconformance for kink/dent in which one device was scrapped prior to further processing.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The product ifu, [t_multi_rev5] ¿multipurpose drainage catheter,¿ provides the following information to the user related 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.¿ evidence gathered upon review of the dmr, ifu, dhr and returned device 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, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported incident.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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: 14835590
• MDR Text Key: 301637246
• Report Number: 1820334-2022-01119
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097650
• UDI-Public: (01)00827002097650(17)241119(10)14366975
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-45-P-6S-CLM-RH
• Device Lot Number: 14366975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 06/28/2022; 02/23/2023
• Supplement Dates FDA Received: 07/25/2022; 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 78 KG