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

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported an unknown patient required an ultrathane multipurpose drainage set for a biliary drainage procedure.The physician attempted to insert the catheter into the patient's body, but the tip of the catheter got stuck and would not advance.A competitor's device was used to successfully 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
D10 ¿ product received on: 28dec2020.Investigation ¿ evaluation: (b)(6) hospital in japan informed cook that on 07dec2020, the catheter in an ultrathane multipurpose drainage set would not advance into the patient¿s skin.The user attempted to place the device via seldinger technique for biliary drainage.When the user tried to insert the device, the catheter tip got ¿stuck¿ and the catheter would not advance.Another manufacturer¿s device was used to complete the procedure.A review of the complaint history, device history record, instructions for use (ifu), and quality control, as well as a visual inspection, and functional test, were conducted during the investigation.One used 8.5fr ult catheter was returned with the metal stiffening cannula and blunt stylet.There is no visible biological matter.The stiffening cannula advances through the catheter without issue and straightens out the pigtail.The blunt stylet was returned inserted into the metal cannula without issue.The stiffener and blunt stylet are able to fully advance through the catheter.The trocar stylet was not returned for evaluation.There is no damage to the catheter distal tip.Additionally, a document based investigation evaluation was performed.Adequate risk mitigation activities are in place to capture potential failure modes prior to customer release.The device history record was reviewed for the complaint lot.The complaint lot did not have related nonconformances.The catheter tubing subassembly lots did not have related nonconformances.There are no additional complaints on the complaint lot.There is no evidence of nonconforming material in house or in the field.Cook concluded the device was manufactured to specification based on the device failure analysis, device history record, device master record, and design history file.There is no evidence of nonconforming material in house or in the field.The instructions for use provided with this lot contain the following precautions: "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 was returned undamaged without the trocar stylet.It is possible that the insertion angle, patient's anatomy, or device selection contributed to the failure.There is no evidence of manufacturing deficiency.Based on the information provided, inspection of returned product and the results of the investigation, the cause of this event is component failure.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 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: 11019923
• Report Number: 1820334-2020-02316
• Device Sequence Number: 17129853
• Product Code: GBO
• UDI-Device Identifier: 00827002272989
• UDI-Public: (01)00827002272989(17)230618(10)13159237
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/22/2021

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: 06/18/2023
• Device Model Number: N/A
• Device Catalogue Number: CLDM-8.5-MH
• Device Lot Number: 13159237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1