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
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter also sent report to fda: unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an unknown patient required the placement of an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for a drainage procedure of a bile duct.The operator stated that when they attempted to insert the drainage catheter into the patient, resistance was felt.The device could not be inserted into the patient's body.Another similar device was utilized to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation (b)(6) hospital (japan) informed cook that a ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was difficult to advance into the patient's body during a bile drainage procedure.When the user noted resistance while advancing the device via seldinger technique, he removed the catheter and replaced it.The patient did not require additional procedures and did not experience adverse effects.A review of the complaint history, device history record, instructions for use (ifu), and quality control were conducted during the investigation.The customer did not return the complaint device due to infectious disease.Therefore, no visual inspection was performed on the complaint device.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) that is shipped with the product was reviewed for information relevant to the reported failure mode.The relevant information includes: "precautions activate the hydrophilic coating, if present, by wetting the catheter with sterile water or saline.For best results, keep catheter surface wet during placement.How supplied.Upon removal from package, inspect the product to ensure no damage has occurred." the device history record (dhr) was reviewed for the lot.The final lot and subassembly lot revealed no related nonconformances.A complaint database search was conducted on the lot provided.The database search revealed no additional complaints for the lot number.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product for visual inspection, and results of the investigation, it was concluded a component failure without design or manufacturing deficiency contributed to this incident.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook 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.
Event or Problem 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
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10139038
• Report Number: 1820334-2020-01107
• Device Sequence Number: 11322873
• Product Code: GBO
• UDI-Device Identifier: 00827002137660
• UDI-Public: (01)00827002137660(17)230409(10)13123780
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 04/09/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-WF-HC
• Device Lot Number: 13123780
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1