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 Discomfort (2330)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 multipurpose drainage catheter for an abdominal drainage procedure.When attempting to remove the drain, the operator reported the suture "appeared to be resisting." this caused pain and discomfort to the patient.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 unknown, unchanged, or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received 11jun2020: the site of the procedure was reported to be the left iliac fossa.

Manufacturer Narrative

Investigation ¿ evaluation: a representative from royal adelaide hospital informed cook of an incident involving a ultrathane mac-loc locking loop multipurpose drainage catheter.On 19may2020 during removal of the pigtail drain, the string was resisting and caused discomfort to the patient during removal.No unintended section of the device remained inside the patient¿s body and the patient did not require additional procedures due to this occurrence.A review of the complaint history, drawing, instructions for use (ifu), and quality control of the device were conducted during the investigation.The complaint device was not returned so a physical examination could not be performed.Since relevant dimensions could not be measured against specification, the device cannot be confirmed to be measured out of specification.However, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks of this device are acceptable when weighed against the benefits.The product labeling was reviewed.The product ifu provides the following information to the user related to the reported failure mode: precautions: -"traction on the locking suture, if present, should be evaluated routinely to ensure continuous function of the catheter." instructions for use: "unlocking catheter loop for mac-loc® locking loop mechanism: a.While stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.B.Pry upward until the locking cam lever is free." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.A global sales shipment report was conducted and cook was unable to narrow down the lot.The customer provided a possible lot, however they were unable to confirm.The device history record for the possible lot and related subassembly lots recorded no related nonconformances.A database search was completed on the possible lot and no complaints were found.There is no evidence suggesting nonconforming product from the affected lot exists in house or in the field.It is possible biological matter contributed to the resistance of the suture.Based on the information provided, no returned product, and the results of the investigation, it was concluded that a component failure without a manufacturing or design deficiency contributed to this event.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 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: 10140312
• MDR Text Key: 196423933
• Report Number: 1820334-2020-01110
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

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: ULT8.5-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 06/08/2020; 07/17/2020
• Supplement Dates FDA Received: 06/17/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1