MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Defective Device (2588)

Patient Problems Pleural Effusion (2010); No Code Available (3191)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

The complaint device was reported to be a "single lumen 3fr cook picc line".(b)(6).(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 patient's bedside nurse was unable to withdraw blood from a single lumen 3fr cook picc line.The device was implanted in the patient's upper left extremity by ir on (b)(6) 2019 to be used for tpn.There were no issues with the device until the bedside nurse was unable to withdraw blood from the line for pre-surgery bloodwork.In the operating room, the surgical team instilled contrast under fluoroscopy to assess the device's integrity.The tip of the line was visualized at the confluence of the svc and the internal jugular.Contrast filled the svc; however, a pleural effusion was noted.In response, the device was locked and use was discontinued.A new device was implanted in the operating room.The complaint device was removed post-surgery in the nicu later that night.Additional information regarding the patient has been requested; however, the submitted report has stated that no additional information is available.

Manufacturer Narrative

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

Additional information regarding the patient was received on 16apr2020.It was reported that the patient did not have a history of pleural effusion until a fluoroscopy was performed to assess picc integrity.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d10, h3, h6- device code.Investigation - evaluation.It was reported that an unknown 3fr single lumen peripherally inserted central venous catheter (picc) was occluded one week after placement.The nurse noticed this failure when attempting to withdraw blood for pre-surgery bloodwork.Cook became aware of this event on 24mar2020 upon being notified by ahs stollery children¿s hospital.A new picc line was inserted and then this device was removed in a following or procedure.A review of the instructions for use (ifu) and quality control of the device, as well as an interview of personnel, was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect related failure modes prior to release.A review of the design history file (dhf) found that this product is both safe and effective for its intended use.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.Based on the available information, cook has concluded that this device was manufactured to specification and that there is no evidence suggesting non-conforming/defective product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document for [cook spectrum turbo-ject peripherally inserted central venous catheters with micropuncture peel-away introducers] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿intended use: cook spectrum turbo-ject peripherally inserted central venous catheter (picc) sets are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in ct studies.Warnings: catheter tip position should be verified by x-ray and monitored on a routine basis.Periodic lateral view x-ray is suggested to assess tip location in relation to vessel wall.Tip position should appear to be parallel to vessel wall.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter maintenance: if blood is not freely aspirated, catheter tip position should be immediately reevaluated by physician.Catheter placement: the catheter tip should be located above the svc-ra junction, within the lower 1/3 of the svc.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause was traced to the procedure.Based on a discussion with the product manager, it is likely that a fibrin sheath caused the inability to withdraw blood from the line.A fibrin sheath likely formed at the distal end of the catheter, allowing insertion of fluid, but preventing withdrawal.The reported pleural effusion is not believed to be related to this event; since the tip was visualized within the svc during contrast injection, the catheter tip is not believed to have perforated the vessel, and therefore likely did not contribute to the reported pleural effusion.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.

Event Description

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

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9899939
• MDR Text Key: 196570959
• Report Number: 1820334-2020-00713
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention