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

Model Number	G21053
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray report source - other - medwatch 4913020000-2021-8005.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a wire guide from a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray kinked during device insertion.During advancement of the wire guide, while it was in approximately 6-8 inches, a 90 degree angle was observed in the wire.As a result, the physician was unable to advance the catheter over the wire.Anesthesia was called to insert a different trans-luminal catheter (tlc) in the patient's left jugular vein.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Event or Problem Description
In additional information received on 17aug2021, it was reported that the central line was inserted for emergency intravenous access.It was confirmed that the failure occurred during wire advancement.The patient had to be stuck in an additional location to gain access for new catheter placement.The patient did not have tortuous anatomy and there was no reported difficulty advancing the wire guide through the access needle.It was confirmed that the patient did not experience any adverse effects due to this occurrence.No unintended section of the device remained in the patient and no hospitalization/prolonged hospitalization was required.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, 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.
Additional Manufacturer Narrative
Upon completion of the investigation, this event is not reportable.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the difficult advancement of a catheter over a bent wire guide, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK SPECTRUM
• 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: 12160540
• Report Number: 1820334-2021-01779
• Device Sequence Number: 3768531
• Product Code: FOZ
• UDI-Device Identifier: 00827002210530
• UDI-Public: (01)00827002210530(17)220101(10)13628350
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2022

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: 01/01/2022
• Device Model Number: G21053
• Device Catalogue Number: C-UTLMY-701J-ABRM-CUSTOM-0018
• Device Lot Number: 13628350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 06/23/2022
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/26/2021; 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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 Age: 76 YR
• Patient Sex: Female