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

Model Number N/A

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/27/2022

Event Type  Injury  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set.Customer (person): postal code: (b)(6).Occupation: risk management.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

During the placement procedure for a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter, the dilator was removed over the guidewire and the guidewire then separated.The remaining portion of the guide wire measuring 35 cm remained in the patient's vessel.The remaining portion of the guidewire was removed in a secondary interventional radiology procedure.No further adverse patient impact was reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.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 provided on 24may2022, it was reported that there was no difficulty advancing the wire guide.There were no back and forth movements of the wire through the needle.There was a bit of resistance (slightly more than normal) advancing the dilator.The physician was surprised when the guidewire was removed and found to be broken.It was believed that the wire broke during that step.Access site was in the right femoral vein.The patient did not have any abnormal or tortuous anatomy.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation alberta health services informed cook on (b)(6) 2022 of an issue with a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set (c-uqlm-1001j-rsc-abrm-hc-rd) from lot 14268803.During the procedure, the dilator was removed over the wire guide, and it was discovered the wire guide separated; approximately 35 cm of the wire was retained in the patient¿s vessel.As a result, the patient required an interventional radiology (ir) procedure to remove the wire.No other adverse events were reported due to this occurrence.Further communication with the customer reported the access site was the right femoral vein.The patient did not have any abnormal or tortuous anatomy.There were no back and forth movements of the wire through the needle.There was no difficulty advancing the wire guide; however, there was some resistance advancing the dilator.The physician believed that the wire broke during that step.Reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One used device was received.Two segments of a wire guide were received along with a catheter.The outer diameter of the wire was measured and found to be within specification.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.In response to this incident, cook reviewed the device history record (dhr).Lot 14268803 showed no additional complaints or nonconformances.Wire guide subassembly lot ic14182107 and dilator subassembly lots showed no related nonconformances.There is no evidence of nonconforming material in house or in the field.Based on the dmr, dhr, and device evaluation, there is no indication the complaint device was manufactured out of specification.Cook also reviewed product labeling.The instructions for use (ifu) c_t_ctulmabrmau_rev7 supplied with the complaint lot were reviewed for information related to reported failure mode.Per the ifu: "warnings -to avoid vascular injury, do not use excessive force when advancing dilators.Use the smallest size dilator catheter placement will allow.Wire guide must always lead dilator by several centimeters.Do not advance dilator more than a few centimeters into the vessel.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.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.5.While maintaining wire guide position, withdraw needle and safe-t-j wire guide straightener.6.Enlarge puncture site with a number 11 scalpel blade, if required.If dilation is required, dilator can be advanced over wire guide and removed prior to insertion of central venous catheter.Caution: to avoid vascular injury, do no use excessive force when advancing the dilators.Use the smallest size dilator catheter placement will allow.Wire guide must always lead dilator by several centimeters.Do not advance dilator more than a few centimeters into the vessel¿ how supplied.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the instructions for use (ifu) c_t_ctulmabrmau_rev7 supplied with the complaint lot were reviewed for information related to reported failure mode.Per the ifu: "warnings to avoid vascular injury, do not use excessive force when advancing dilators.Use the smallest size dilator catheter placement will allow.Wire guide must always lead dilator by several centimeters.Do not advance dilator more than a few centimeters into the vessel.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¿ 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.5.While maintaining wire guide position, withdraw needle and safe-t-j wire guide straightener.6.Enlarge puncture site with a number 11 scalpel blade, if required.If dilation is required, dilator can be advanced over wire guide and removed prior to insertion of central venous catheter.Caution: to avoid vascular injury, do no use excessive force when advancing the dilators.Use the smallest size dilator catheter placement will allow.Wire guide must always lead dilator by several centimeters.Do not advance dilator more than a few centimeters into the vessel.How supplied.Upon removal from package, inspect the product to ensure no damage has occurred.¿ 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 component failure.The customer stated that during advancement of the dilator, resistance was felt.It is possible that the wire became stuck and excessive force was applied causing the wire guide to break.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
• 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: 14189157
• MDR Text Key: 289896279
• Report Number: 1820334-2022-00641
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002515390
• UDI-Public: (01)00827002515390(17)240622(10)14268803
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UQLM-1001J-RSC-ABRM-HC-RD
• Device Lot Number: 14268803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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