MAUDE Adverse Event Report: COOK INC ULTRATHANE MULTIPURPOSE DRAINAGE SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an ultrathane multipurpose drainage set for bile duct drainage.The wire guide was successfully placed in the patient.When the physician attempted to insert the drainage catheter, it "could not be inserted into the patient's body." the operator reported that the tip of the catheter was frayed.Another similar device was used to complete the procedure.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 in japan informed cook that on (b)(6) 2020 they had difficulty inserting an ultrathane multipurpose drainage set into the patient's body.The catheter was placed via seldinger technique but would not advance past the patient's skin.They removed the device and noted that the tip was damaged after the attempted placement.A new device was used to complete the procedure without adverse effects to the patient.A review of the complaint history, device history record, instructions for use (ifu), and quality control of the 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.There are appropriate inspection activities in place to address this failure prior to distribution.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "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." a review of the device history record (dhr) was also conducted as a part of the investigation.The catheter tubing subassembly had a related nonconformance but all nonconforming devices were scrapped and this device is 100% visually inspected for this related nonconformance.There were no additional failure related nonconformances on the lot or subassemblies.A complaint history search found no other complaints from the reported lot.Therefore, there is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product and the results of the investigation, the cause of this complaint is component failure without design or manufacturing deficiency.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 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 MULTIPURPOSE DRAINAGE SET
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10283768
• Report Number: 1820334-2020-01308
• Device Sequence Number: 19005244
• Product Code: GBO
• UDI-Device Identifier: 00827002272989
• UDI-Public: (01)00827002272989(17)230427(10)13016879
• 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): 09/09/2020

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: 04/27/2023
• Device Model Number: N/A
• Device Catalogue Number: CLDM-8.5-MH
• Device Lot Number: 13016879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1