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 Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that a patient required replacement of an ultrathane mac-loc locking loop multipurpose drainage catheter.It was noted at an unknown time post placement, the hub was separated from the catheter, not allowing chest tube to suction properly.The patient returned to interventional radiology for device exchange.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Reporter occupation: manager, supply chain services.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.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.

Manufacturer Narrative

Additional information: 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

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

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by a representative of (b)(6) hospital (florida, usa) that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult14.0-38-25-p-6s-clm-rh; lot# 10073914) separated.The device was placed in the patient for use as a chest tube.Later, it was discovered that the mac-loc hub separated from the catheter which exposed the inner suture and prevented proper suction.A photo was provided showing the device separation.The physician was notified to assess the catheter.The patient returned to interventional radiology where the catheter was removed and replaced.No other adverse effects were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), drawings, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, as well as a visual inspection of the customer provided photo, were conducted during the investigation.The complaint device was not returned.However, based on the provided photo from the customer, it was confirmed the proximal mac-loc adaptor separated from the catheter.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide a lot number for this device.Therefore, cook medical inc.Performed an expanded sales search for the reported device and discovered a single lot, 10073914, sold to this facility.The dhr for lot 10073914 and related subassembly lot records no relevant non-conformances.The torque driver used in the manufacturing of this lot passed calibration.A further search of the reported lot number confirmed no additional complaints being received.Appropriate measures have been taken to address this failure mode.A capa was previously opened to further investigate this failure mode.Corrective actions have since been implemented following the manufacture of this device.Lot 10073914 was manufactured after corrective action implementation.Based on the dmr and dhr, there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Cook reviewed the product labeling for the complaint device.The instructions for use(ifu) [ t_multi_rev5], multipurpose drainage catheter] states the following.Precautions: patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.How supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the customer provided photo, and the results of the investigation, it was determined the cause of this event is related to component failure, unrelated to a design or manufacturing deficiency.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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
• 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: 15245528
• MDR Text Key: 298109093
• Report Number: 1820334-2022-01354
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095045
• UDI-Public: (01)00827002095045(17)221010(10)10073914
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-25-P-6S-CLM-RH
• Device Lot Number: 10073914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 01/12/2023; 02/21/2023
• Supplement Dates FDA Received: 01/24/2023; 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention