MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY 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 02/06/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Additional product codes: fge, lje.Pma/510(k) #: k173035.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 male patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for a drainage procedure.During the procedure, the catheter was difficult to advance.Upon removal it was noted there was a kink on the catheter.A new 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.

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 unknown, unavailable, or unchanged.Investigation - evaluation: (b)(6) med.Device in china informed cook on (b)(6) 2021 of an incident involving an ultrathane mac-loc locking loop biliary drainage catheter [rpn: ult8.5-38-40-p-32s-clb-rh] from lot number 10282498.During a procedure, it was difficult to advance the catheter in the patient.The catheter was removed from the patient and a kink was discovered.A new device was used to complete the procedure.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence, and there have been no adverse effects to the patient due to this occurrence.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection and dimensional verification of the returned device, was conducted during the investigation.One used 8.5 fr ult catheter with the stiffening cannula and blunt stylet fully inserted and locked onto the catheter was returned to cook for evaluation.The stiffener and stylet were able to be removed from the catheter without difficulty.Once removed, the catheter shaft was noted to be slightly wavy.No other damage on the catheter was noted.Relevant measurements were taken and found to be within manufacturing tolerance.Cook has concluded that this device was manufactured to specification.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (10282498) and the related catheter subassembly lots revealed a related nonconformance for "coating, hc coverage insufficient irregular" in which three devices were scrapped as well as a related nonconformance for "surface, defect" in which four devices were scrapped.There is a 100% inspection for both of these non-conformances prior to release.A database search did not identify any other events associated with the reported device lot.As there are adequate inspection activities established, there is objective evidence that the dhr was fully executed, and there are no additional complaints from the same lot, cook has concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿multipurpose drainage catheter¿ [t_multi_rev5], provides the following information to the user related to the reported failure mode: intended use: -¿multipurpose drainage catheters are intended for percutaneous drainage in a verity of drainage applications (e.G., nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.¿ 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." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event has been traced to component failure unrelated to a deficiency in manufacturing/device design.It is possible that the hydrophilic coating was not activated, which can cause difficulty advancing the catheter into the patient.In addition, tortuous patient anatomy can also result in difficult advancement.However, these cannot be confirmed without additional information.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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY 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: 11368529
• MDR Text Key: 233290134
• Report Number: 1820334-2021-00379
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)230122(10)10282498
• 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: 05/24/2021

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: 01/22/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 10282498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 65