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

Model Number N/A

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423)

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

Event Type  malfunction  

Event Description

It was reported the customer experienced persistent issues with the catheter of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray.These issues were discovered due to specific increased need for tpa usage for the blue proximal lumen.One incident involved the central venous catheter of an unknown patient being replaced, and an issue of the inability to obtain blood return from the blue lumen of the device being immediately noticed post-insertion.Another separate incident involved leakage around the insertion site when the lumen was flushed.Overall, the main issue was the inability to flush the proximal port while the line was inserted in the femoral vein and internal jugular cannulations.This report covers the incident of the line inability to obtain blood return under the patient identifier (b)(6).An additional report will cover the inability to flush the lumen under the patient identifier (b)(6).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.D1 - device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray.E3 - occupation: strategic sourcing manager.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

Blank fields on this form indicate the information is unknown, unavailable, or unavailable.Additional information: b5 correction: h6 - annex e, 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.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

Per additional information, the unused lumens were maintained via heparin-locked.The catheter required replacement.The patient did not experience any adverse effects, additional procedures, or prolonged hospitalization.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a investigation ¿ evaluation on (b)(6) 2023, an issue was reported with a catheter from the cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray.A line was replaced and immediately had issues post-insertion with inability to obtain blood return from the blue lumen.The unused lumens were maintained via heparin-lock.Another line was needed to replace the failure.No adverse effects, additional procedures, or prolonged hospitalization were identified for the patient.Reviews of the documentation, including the complaint history, instructions for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) was completed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) could not be conducted due to the lack of lot information provided by the facility.Cook medical inc.Performed an expanded sales search to determine the lot number; however, the identity of the complaint lot was unable to be determined.Cook was also able to review product labeling.The product ifu, [c_t_ulmabrm_rev4] ¿spectrum and spectrum glide central venous catheter,¿ provides the following in relation to the reported failure mode: product recommendations suggested lumen utilization: double-lumen ¿- #1 distal exit port (endhole) ¿ whole blood or blood product delivery and sampling; any situation requiring more flow rate; cvp monitoring; medication delivery.It is strongly recommended that this lumen be used for all blood sampling.- #2 proximal exit port- medication delivery; acute hyperalimentation¿ suggested catheter maintenance ¿ -to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, 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.¿ instrucitons for use ¿8.-lumens should now be flushed with 5-10 cc normal saline prior to use or establishment of heparin lock.¿ evidence gathered upon review of dmr and ifu, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product, and the results of our investigation, it was determined that an unintended use error contributed to the event.It is possible that line #2 was not filled with saline solution or heparinized saline solution prior to catheter introduction, resulting in the line clotting and preventing lumen flow, but cook cannot confirm this.The ifu strongly recommends using the distal exit port #1 for all blood sampling.The customer stated immediate difficulties getting blood through the blue lumen (line#2).The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 patient and/or event details has been received since the previous medwatch report was sent.

• 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: 17292666
• MDR Text Key: 318900495
• Report Number: 1820334-2023-00884
• Device Sequence Number: 1
• Product Code: FOZ
• 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
• Report Date: 12/27/2023

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: C-UDLMY-401J-ABRM-HC-FST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/19/2023; 11/30/2023
• Supplement Dates FDA Received: 07/28/2023; 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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