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

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

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 Description

It was discovered upon device return that the wire guide of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter had separated.It was initially reported that the wire guide was difficult to remove from the device as it was withdrawn following catheter placement in the subclavian vein.The physician removed both the wire and catheter together and opened a new device for an attempted second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 one wire guide was separated.Two occluded catheters were also found and are referenced in the report with patient identifier: (b)(6).

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: (b)(6) returned the wire guide of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter in a separated condition.It was initially reported on 31mar2021 that the wire guide was difficult to remove from the device 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 one wire guide was separated.Two occluded catheters were also found upon device return and are referenced in the medwatch report 1820334-2021-01366.A review of the complaint history, device history record, instructions for use (ifu), and quality control, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The device was received in a used condition.The wire guide is kinked and slightly bowed.The wire is broken at the proximal weld.The coils were not elongated and there was no protrusion of mandril wire.The outer diameter of the wire guide and inner diameter of catheter end hole were within specification.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot and relevant sub-assembly lots revealed no recorded non-conformances relevant to the failure mode.A database search revealed one other complaint associated with the reported device lot that occurred during the same procedure with the same user; the other complaint is difficult removal of wire guide during the procedure that led to wire guide kinking.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: instructions for use: ¿4.-if resistance is encountered during wire guide insertion, do not force wire guide.¿ how supplied: ¿ upon removal from package, inspect the product to unsure no damage has occurred.¿ based on the available information, inspection of the returned device, and the results of the investigation, the cause of this event is component failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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: 11852397
• MDR Text Key: 266891482
• Report Number: 1820334-2021-01365
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002508170
• UDI-Public: (01)00827002508170(17)220608(10)13069664
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 74 KG