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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set.Customer (person): phone: (b)(6).Reporter occupation: general manager.Report source, other: internal personnel.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the wire of a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set separated upon removal from the patient.The physician used the seldinger technique through the subclavian vein to introduce the wire with no issues.There was no difficulty gaining access to the intended vessel or dilating the tissue, and the vessel was accessed on the first attempt.During vessel access, the wire was not repositioned.The wire was not manipulated through a needle.The device was placed in the subclavian without any supporting imaging to assist.Upon removal of the wire, it was found to be broken.The wire could not be removed fully as it was stuck in the patient's muscular tissue and inside the vessel.The patient was taken to the emergency room for an additional surgery to remove the wire.The subcutaneous tissue was explored and the separated piece of wire was removed without complications.No other adverse effects have been reported.

Event Description

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

Manufacturer Narrative

Additional information: section c.Investigation ¿ evaluation: it was reported that a wire guide from a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set (c-uqlm-1001j-rsc-abrm-hc-rd) from lot 10301064 broke.A fragment separated and became embedded in subcutaneous tissue, requiring surgery to remove.Cook became aware of this event on (b)(6) 2020 upon being notified by from (b)(6).The patient reportedly experienced no additional adverse effects as a result of this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control of the device were conducted during the investigation.The complaint device was not returned for evaluation.A document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file shows evidence of validations in place to meet design requirements related to this failure mode.A review of the device history record found one related nonconformance for the wire guide subassembly lot in which one device was scrapped due to a broken solder.A database search found one additional complaint from this device lot, reported by the same user facility for the same failure mode.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: "precautions standard seldinger technique for placement for placement of percutaneous vascular access sheaths, catheters and wire guides should be employed during the placement of a central venous catheter.Instructions for use 4.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: upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned, and the results of the investigation, a definitive cause for separation was established as component failure unrelated to a manufacturing or design deficiency.Historical analysis of previous complaints has shown that withdrawal of the wire through the needle typically leads to wire guide damage.However, the customer reported not performing this action so this cause is not suspected.Forceful manipulation of the wire guide and/or tortuous patient anatomy may have contributed to the damage, but these cannot be confirmed without additional information.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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
• MDR Report Key: 10368886
• MDR Text Key: 203500912
• Report Number: 1820334-2020-01435
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002515390
• UDI-Public: (01)00827002515390(17)221120(10)10301064
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UQLM-1001J-RSC-ABRM-HC-RD
• Device Lot Number: 10301064
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 86