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	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a (b)(6), female patient underwent placement of a cook spectrum minocycline /rifampin impregnated double lumen central venous catheter.While the physician was advancing the wire guide into the patient, he felt resistance.He withdrew the wire and found it "deformed." a provided photo of the device showed unraveling of the wire guide.The physician completed the procedure by using another set.The anatomical site of placement was the right rib.The anatomy of the access vessel was not tortuous.No difficulty was noticed after the needle was removed.Imaging was not used in the placement of the device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Device name: cook spectrum minocycline /rifampin impregnated double lumen central venous catheter.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Lin shin hospital informed cook on 19nov2021 of an incident involving a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter (c-udlm-801j-abrm-hc) from lot 13774513.The wire guide reportedly elongated during advancement for a central venous catheter placement procedure on (b)(6) 2021.The patient did not require any additional procedures and did not experience any adverse effects.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One used device was received.Visual examination showed the elongation starts at 18cm from the proximal end and is 7cm in length.The inner core was protruding at approximately 25cm.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.The device history record (dhr) for lot 13774513 and for lot ic13650380 record no relevant non-conformances.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_udlm_rev2] ¿8 french double-lumen central venous catheter,¿ provides the following information to the user related to the reported failure mode: precautions: ¿use of ecg, ultrasound and/or fluoroscopy is suggested for actuate catheter placement.¿ how supplied: ¿upon removal from package, inspect the package to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of return device, suggest that there is no evidence the device was manufactured out of specification, or that there are non-conforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to unintended user error.The instructions for use provided with this device suggest using imaging for accurate catheter placement.The user in this case did not use imaging.The lack of imaging guidance could have caused the wire guide to advance into the vessel wall, leading to the reported failure.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.

• 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: 12920481
• Report Number: 1820334-2021-02623
• Device Sequence Number: 5271503
• Product Code: FOZ
• UDI-Device Identifier: 00827002508170
• UDI-Public: (01)00827002508170(17)231215(10)13774513
• 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,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 12/15/2023
• Device Model Number: N/A
• Device Catalogue Number: C-UDLM-801J-ABRM-HC
• Device Lot Number: 13774513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 58 KG