MAUDE Adverse Event Report: COOK INC COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problems Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D1 - device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray.E3 - occupation: purchasing agent.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 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 or that a death or serious injury occurred; nor is it admission 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

It was reported that catheters from cook spectrum minocycline/rifampin impregnated double lumen central venous catheter trays were occluded."hours" after the devices were placed in the patients, blood could not be drawn, and clots occurred.Occlusive clots and deep vein thromboses were reported.As a result, the patients required blood thinner administration and prolonged hospitalization.No other adverse effects were reported for these incidents.

Event Description

In additional information it was reported that the catheter was placed in the left femoral on (b)(6) 2023 at 23:35hrs.Heparin flush was ordered when the line was place.Tpa was administered on (b)(6) 2023 at 17:16hrs and (b)(6) 2023 10:30hrs.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d4 - lot number.Possible lot numbers are 15214797 and 15291463, d4 - expiration date, h4 additional information: b5, h6 - annex f 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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.It was reported that the catheter from cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray occluded.The catheter was placed in the left femoral on 12jun2023 at 23:35hrs.Heparin flush was ordered when the line was placed."hours" after the device was placed in the patient, blood could not be drawn, and clots occurred.Tissue-type plasminogen activator (tpa) was administered on 13jun2023 at 17:16hrs and on 16jun 2023 at 10:30hrs.No adverse effects were reported due to this event.Reviews of the complaint history, device history record (dhr), quality control, and instructions for use (ifu), 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.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 dhr for the reported complaint device lot and related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A complaint history search identified one additional complaint from the same facility associated with the reported device lot for a similar failure.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu (c_t_ulmabrm_rev4) packaged with the device contains the following in relation to the reported failure mode: "suggested catheter maintenance ¿ to prevent clotting or possibility of air embolus, the double-lumen¿s #2, and the triple-lumen¿s #2 and #3 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per cc of saline is usually adequate), depending on institutional protocol, prior to catheter introduction.¿ before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock." based on the available information, no product returned, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is unknown if the customer flushed the device before and after each use.It is also unknown if the heparin-locked lumens were reestablished every 8 hours.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.

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 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 or that a death or serious injury occurred; nor is it admission 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 information was provided indicating this patient experienced a dvt.The patient who experienced the dvt is capture in report #1820334-2023-00829.

• Brand Name: COOK SPECTRUM
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 17212000
• MDR Text Key: 317984530
• Report Number: 1820334-2023-00830
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002480537
• UDI-Public: (01)00827002480537(17)250207(10)15291463
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K033843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/26/2023

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 Model Number: N/A
• Device Catalogue Number: C-UDLMY-401J-ABRM-HC-IHI-FST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 07/10/2023; 10/30/2023; 11/29/2023
• Supplement Dates FDA Received: 07/21/2023; 11/01/2023; 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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