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

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter.Initial reporter customer (person), phone number:(b)(6).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 discovered upon device return that the catheters of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter had occluded.It was initially reported that the wire guide was difficult to remove from the device as it was withdrawn following catheter placement in the subclavian vein.The physician removed both the wire and catheter together and opened a new device for an attempted second placement.The same issue with difficult wire removal occurred with the new device.A third device was opened to successfully complete the procedure.It was later reported that imaging guidance was used to place the catheter, and no resistance was felt when advancing the wire guide.During placement, the distal tip of the wire was always leading the distal tip of the catheter.Upon return of the two complaint devices to the manufacturer, it was discovered that both catheters were occluded.One separated wire guide was also found and is referenced in the report with patient identifier: (b)(6).
Event or Problem Description
No new patient and/or event information.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, this event is not reportable.This report was submitted based on the condition of returned devices for a complaint on difficulty removing a wire from the catheter.The user reported no difficulty advancing the wire through the catheter.It was determined that the likely cause of the occlusion was biomatter during transit to the manufacturer.The occluded condition of the returned device was expected due to its used condition.As there is no communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device and the status of the returned device was expected due to its used condition, this does not meet the definition of a complaint or reportable event.

• 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: 11852479
• Report Number: 1820334-2021-01366
• Device Sequence Number: 16931109
• Product Code: FOZ
• UDI-Device Identifier: 00827002508170
• UDI-Public: (01)00827002508170(17)220608(10)13069664
• Combination Product (Y/N): Y
• 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,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 06/08/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UDLM-801J-ABRM-HC
• Device Lot Number: 13069664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2020
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 74 KG