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 Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product identifier: the gpn of the device is either a g09502, g09503 or g09504.Customer (person): (b)(6).Occupation: clinical nurse specialist.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 the metal stylet of an ultrathane mac-loc locking loop multipurpose drainage catheter caused severe trauma and permanent damage to the life of a patient.The general practice of the hospital was to throw the metal stylet out and not use it for device placement.However, when the registrar was carrying out the procedure, the metal stylet was used in the drain.As a result, the patient suffered a severe adverse outcome with possible perforation of the pulmonary artery.Although the patient is still alive, this incident has caused a severe lifelong impact to the patient's quality of life.Additional information regarding event and patient details have been requested, but are unavailable at this time.

Manufacturer Narrative

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

In additional information received on 20oct2021, it was reported that the device was placed in the chest.The device is typically used in a theater and an ir setting, but in this instance was used in theater.Normally, the seldinger technique is used to insert the device, while the metal stiffener is not used.In this instance, normal protocol for the theater was not being followed.

Manufacturer Narrative

Correction: annex a.Investigation ¿ evaluation: a representative from (b)(6) hospital (b)(6) in australia that the metal stiffener of an unknown ultrathane mac-loc locking loop multipurpose drainage catheter was used during a procedure in the chest that resulted in severe trauma.A review of the instructions for use (ifu), manufacturing instructions and quality control checks were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.The device master record (dmr) was reviewed and device drawings, manufacturing instructions, quality control procedures, and specifications were identified.Sufficient controls are in place to detect this failure mode prior to release.The product¿s design history file (dhf) has controls in place to address the failure.The customer did not provide a lot number for this device.However, additional lots were provided by the customer.Therefore, cook medical inc.Performed an expanded review of the provided lot numbers, confirming there were no relevant recorded nonconformances.There is objective evidence the dhr was executed, and there are no additional field complaints on these lots.Cook did not find evidence of nonconforming material in house or in the field.Cook concluded that the device was manufactured to specification.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: 'precautions" these products are intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of percutaneous drainage catheters should be employed.Manipulation of products requires ultrasound, fluoroscopy, or other imaging guidance.The customer reported that using the metal stiffener is not a common practice in their facility.The user in this event inadvertently perforated the patients pulmonary artery with the metal stiffener included in the drainage set.Based on the information provided the root cause category would fall under unintended use error.The appropriate internal personnel have been notified.Per the 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
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12557842
• MDR Text Key: 274317828
• Report Number: 1820334-2021-02263
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 10/18/2021; 02/08/2022
• Supplement Dates FDA Received: 11/04/2021; 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability