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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the device failure was clarified that the wire guide of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray unraveled.A second attempt and poke was done with a new kit to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D1 - device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.E3 - occupation: clinical nurse specialist.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported that the wire guide in a 'cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray' unraveled.The procedure was completed with a replacement device.No adverse effects have been reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the returned device were conducted during the investigation.One used wire guide was received for evaluation.The wire guide started elongating at 3.8cm from the proximal end.The overall length of the elongation is 46.7cm.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.Cook also reviewed the dhr and no nonconformances were recorded, and the wire guide subassembly lots showed no related nonconformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook also reviewed product labeling.The product ifu, [c_t_ulmabrm_rev4] ¿spectrum and spectrum glide central venous catheters,¿ provides the following information to the user related to the reported failure mode: ¿instructions for use -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 dmr, dhr, ifu, and device failure analysis, there is no indication the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded the cause of event to be component failure unrelated to any manufacturing or design deficiencies.It is possible that the wire guide was manipulated or withdrawn through the needle, resulting in the elongation.It is also possible the wire was damaged during advancement and elongated upon attempted removal.However, cook cannot confirm this without additional information.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Common Device Name: 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: 18086188
• Report Number: 1820334-2023-01511
• Device Sequence Number: 7692293
• Product Code: FOZ
• UDI-Device Identifier: 00827002440159
• UDI-Public: (01)00827002440159(17)240801(10)14965001
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-501J-RSC-ABRM-HC-FST
• Device Lot Number: 14965001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown