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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the blue flexible stiffener was difficult to remove from an ultrathane mac-loc locking loop multipurpose drainage catheter 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 difficult removal of the stiffener from the catheter.The second instance of stiffener separation has been captured in a report with patient identifier: (b)(6).
Additional 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 or Problem 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.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.It was reported that upon the placement of an ultrathane mac-loc locking loop multipurpose drainage catheter, difficulty was encountered when removing the flexible stiffener from the catheter.This caused the stiffener to be to stretched super thin, almost doubling the length of the stiffener.Another catheter from the same lot was then used; however, the stiffener broke apart (mfg.Report reference #: 1820334-2023-00839).The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), quality control procedures and specifications, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.The supplied flexible stiffener was returned for evaluation in a used and damaged condition.Material elongation of the stiffener was confirmed upon visual examination.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.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 device history record (dhr) for the device lot found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number at the time of the investigation.An expanded search of additional lots related to the flexible stiffener found no other related complaints.Cook was also reviewed 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, dhr, ifu, and returned device suggests that the device was manufactured to 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 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
• Common Device Name: 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: 17218210
• Report Number: 1820334-2023-00836
• Device Sequence Number: 3022643
• Product Code: GBO
• UDI-Device Identifier: 00827002097667
• UDI-Public: (01)00827002097667(17)260310(10)15269273
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2026
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 11/08/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/26/2023; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 64 KG