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 Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown 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 Description

It was reported a (b)(6) patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for a percutaneous transhepatic cholangiography and drainage(ptcd) procedure.While trying to advance the catheter, the operator reported feeling significant resistance.The operator was attempting to place the device via direct stick and the access site was pre-dilator prior to catheter introduction.Another device was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

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 unchanged, unknown, or unavailable.Investigation ¿ evaluation guangzhou pumei medical tech.In china informed cook that on (b)(6) 2021, a user had difficulty advancing an ultrathane mac-loc locking loop multipurpose drainage catheter from lot 13239204 into the patient.The user predilated the access site with an 8.0fr catheter and inserted the ult catheter into the patient via direct stick.They noted significant resistance while trying to advance the ult catheter and removed the device.A new device was used to successfully 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 dimensional verification of the returned device, were conducted during the investigation.The customer returned one ult catheter with the stiffening cannula and trocar stylet inserted.The trocar exits the catheter 1mm measuring from heel of the bevel to tip of catheter, which is within specification.There is no visible damage to the catheter or components.The catheter outer diameter measures within specification.Additionally, a document based investigation evaluation was performed.There are appropriate controls in place to detect this failure.The design history file indicates adequate risk mitigation activities are in place to capture potential failure modes prior to customer release.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 to check for failure related nonconformances and additional complaints.The dhr for the complaint lot did not have related nonconformances.The tubing subassembly lot did not have nonconformances.There are no additional complaints on lot 13239204.Therefore, there is no evidence of nonconforming material in house or in the field.It is possible that the angle of access or patient's anatomy contributed to the resistance, but this was not confirmed.There is no evidence of manufacturing deficiency, therefore 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.

• 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
• MDR Report Key: 11247951
• MDR Text Key: 245791447
• Report Number: 1820334-2021-00196
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)230611(10)13239204
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 13239204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK JCD8.0-38-20 DILATOR
• Patient Age: 45 YR
• Patient Weight: 59