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

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Brand name: (b)(6).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 wire of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set separated, requiring an additional surgical procedure to remove from the patient.The physician felt resistance as the wire guide was advanced into the subclavian vein of the patient.The wire was moved back and forward in order to continue advancement.As the wire was withdrawn, it was found to be "cut off." the separated section of wire guide remained in the body of the patient, and an emergent procedure in the operating room was performed to successfully retrieve it.Additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.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 wire of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set separated, requiring an additional surgical procedure to remove from the patient.The physician felt resistance as the wire guide was advanced into the subclavian vein of the patient.The wire was moved back and forward in order to continue advancement.As the wire was withdrawn, it was found to be "cut off." the separated section of wire guide remained in the body of the patient, and an emergent procedure in the operating room was performed to successfully retrieve it.Additional information regarding event details has been requested, but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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, it was reported that the wire guide was manipulated through the needle.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by pang yeng yu of cender hospital located in taiwan that on 17nov2021 the wire guide in a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (rpn: (b)(4), lot# 13980666) separated.During advancement of the wire guide into the patient¿s neck, resistance was encountered.The user then withdrew and advanced the wire guide several times to aid in advancement.When the wire was removed from the patient, separation was observed, and a portion of the wire guide was retained in the patient.As a result, emergency surgery was scheduled, and the fragment was removed in the operating room.Further communication with the customer clarified that the wire was manipulated through a needle.No other adverse events were reported due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control, manufacturing instructions (mi), 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.Four additional final lots related to the subassembly lots were also reviewed and revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.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 field cook also reviewed product labeling.The product ifu, [c_t_ctulmabrm_rev7] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable,¿ provides the following information to the user related to the reported failure mode: instructions for use: ¿4.Slide safe-t-j wire guide straightener (positioned on distal tip of wire guide) over ¿j¿ portion of wire guide.Pass straightened wire guide through needle; advance wire guide 5-10 cm into vessel.If straight wire is used, always advance soft, flexible end through needle hub and into vessel.If resistance is encountered during wire guide insertion, do not force wire guide.Withdrawal of wire guide through needle should be avoided; breakage may result.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, no device return, and the results of the investigation, cook has determined unintended use error contributed to this event.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: 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: 12917703
• MDR Text Key: 286017865
• Report Number: 1820334-2021-02622
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)240309(10)13980666
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 13980666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/28/2021; 07/29/2022
• Supplement Dates FDA Received: 01/06/2022; 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 50 KG