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 Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): alternate email: (b)(6), e3 - occupation: buyer, g4 - 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 the blue flexible stiffener of an ultrathane mac-loc locking loop multipurpose drainage catheter separated during an unknown procedure.The stiffener and catheter were prepped with saline before putting the system together.The catheter was then loaded over the wire into the patient without issues.While removing the plastic stiffener, the physician noted that it would not come out easily.The stiffener had stretched to almost double the length of its original size upon removal.Another catheter of the same lot was opened to continue the procedure; however, the stiffener from this set broke apart during use, leading to more extensive work from the physician to complete the procedure.The physician noted that the stiffener was getting "held up" from where the hub connects to the catheter.It is currently unknown if the patient experienced any adverse effects or required any additional procedures due to this occurrence.Additional information regarding patient and event details has been requested but is currently unavailable.The report references the instance of stiffener separation.The first instance of difficult stiffener removal has been captured in a report with patient identifier: (b)(6).

Event Description

Per additional information provided on 25jul2023, the patient had an ileal conduit bilateral percutaneous nephrostomy exchange procedure which required longer fluoro time and laying on the table.The blue flexible stiffener broke apart into two pieces.The fragment was stuck inside of the catheter but was removed.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, b7, e4 correction: a2, a3, a4, h6 - annex e, annex f 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, unavailable, or unchanged.Investigation ¿ evaluation it was reported that the blue flexible stiffener of an ultrathane mac-loc locking loop multipurpose drainage catheter separated.The stiffener and catheter were prepped with saline before putting the system together.The catheter was then loaded over the wire into the patient without issues.While removing the plastic stiffener, the physician noted that it would not come out easily.The stiffener had stretched to almost double the length of its original size upon removal.Another catheter of the same lot was opened to continue the procedure; however, the stiffener from this set broke apart into two pieces.The fragment was stuck inside of the catheter but was removed.The physician noted that the stiffener was getting "held up" from where the hub connects to the catheter.The patient did not experience any adverse effects or require any additional procedures, the first instance of difficult removal of the stiffener was captured under mdr # 1820334-2023-00836.This report references the second instance in which the stiffener separated.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used and damaged blue flexible stiffener was returned to cook for evaluation.The flexible stiffener was returned in two sections.One section exhibited extreme material elongation throughout the entire length.Additionally, the distal end of this separated section showed material elongation, confirming the point of separation.The outer diameter of the blue flexible stiffener was confirmed 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 mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.A database search identified one additional event from the same user facility reporting the same difficulty associated with the reported device lot.An expanded search was performed on the applied raw lot for the blue flexible stiffener.The search identified an additional 21 lots that received lot, with only the two reported complaints mentioned above being received.Cook reviewed the product labeling.The product ifu, [t_multi2_rev1] ¿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.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, dhr and device evaluation 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, inspection of the returned device, and the results of the investigation, cook medical has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9 correction: d2a.D2b, g4 d2a - additional common name: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy d2b - additional product code: gbo; lje g4 - pma/510(k) #: k173035 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 patient and/or event details 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: 17218501
• MDR Text Key: 318043438
• Report Number: 1820334-2023-00839
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002097667
• UDI-Public: (01)00827002097667(17)260310(10)15269273
• 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,Followup
• Report Date: 01/30/2024
• 2 Devices were Involved in the Event: 1 2

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: ULT10.2-38-45-P-6S-CLM-RH
• Device Lot Number: 15269273
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/25/2023; 01/02/2024; 01/12/2024
• Supplement Dates FDA Received: 07/26/2023; 01/04/2024; 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 64 KG