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 Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

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 that an unknown patient required the placement of ultrathane mac-loc locking loop multipurpose drainage catheter for a nephrostomy tube exchange of an ileal conduit drain.The operator reported they "were unable to remove the blue stylet" from the drain after it was exchanged.The operator reports having to "cut the drain" in order for stylet to be removed.The operator reports using another similar device and completing the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10--product received on: 09jan2020.Investigation-evaluation: it was reported to cook that the flexible stiffener within a ultrathane mac-loc locking loop multipurpose drainage catheter could not be removed from the catheter.This incident was reported by (b)(6) hosp, in the united states, on (b)(6) 2019.The device was removed, and another was placed to successfully complete the procedure.No adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and functional test, were conducted during the investigation.The complainant returned one sealed device and one used flexible stiffener for investigation.The sealed device was opened, and the flexible stiffener was inserted into the catheter without difficulty and removed without difficulty.The used flexible stiffener was received in two sections.Both sections were severely elongated.Due to the damaged state the device was returned in, no dimensional analysis could be completed for the used device.The unused device was analyzed however, and at this time there is no evidence suggesting that either device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) was reviewed.The final, subassembly, and raw material lots were reviewed and revealed no nonconformances relevant to the reported failure mode.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Product labeling was also reviewed.Instructions for use are packaged with this device.Relevant sections include: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ based on the information provided, inspection of returned product and the results of the investigation, it was concluded that a component failure without manufacturing or design 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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9497100
• MDR Text Key: 175903151
• Report Number: 1820334-2019-03156
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-45-P-6S-CLM-RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1