MAUDE Adverse Event Report: COOK INC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Catalog Number UPICDS-4.0-CT-40NT-ABRM-1111

Device Problem Complete Blockage (1094)

Patient Problems Thromboembolism (2654); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Spectrum turbo-ject single lumen minocycline/rifampin bedside power-injectable picc.Pma/510(k) #: k100974.(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 the patient developed venous thromboembolism (vte) after a spectrum turbo-ject single lumen minocycline/rifampin bedside power-injectable picc was placed.The line clotted between day three and four after placed.As reported, the drop was at the optimal tip position and inserted into veins of optimal size for selected catheters with no issues.It is unknown if the reported device will be returned.To date, additional information regarding the event, device lot and current patient status has been requested but not provided.

Manufacturer Narrative

Date of event estimated to be (b)(6) 2018, reported event occurred 3-4 days after placement.Additional information received identified the picc line placement procedure took place (b)(6) 2018.It was also reported the procedure entailed one attempt in the left brachial cut at 30 cm with optimal position.Additionally, it was reported the catheter was removed and replaced by exchange over a wire with another one.The reporter stated the patient was a difficult patient and the vte may or may not have been caused by the type of picc placed.(b)(4).

Event Description

No additional information has been reported since the submission of the follow up report on 06/11/2018.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable or has been previously reported.Investigation - evaluation: the complaint device was not returned; therefore no physical examination could be performed.There is no evidence to suggest the device was not manufactured to specifications, and there is no evidence to suggest the catheter was placed incorrectly.The facility also reported that the patient involved was known to be difficult and it is possible the device did not cause the adverse event.The ifu shipped with this device gives information based on preliminary reports that describe the relationship between catheter size and potential for clot formation.The manufacturing and quality control documents for the wire guide were reviewed, and the appropriate controls are in place to ensure the device is manufactured to specifications.The device history record was reviewed and no related non-conformities were found.There is no evidence to suggest the device was not manufactured to specifications.There have been no additional reported complaints associated with the product lot.There is no evidence to suggest there are non-conforming devices in house or in field.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed 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.

• Type of Device: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7507300
• MDR Text Key: 108007033
• Report Number: 1820334-2018-01443
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K133634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UPICDS-4.0-CT-40NT-ABRM-1111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR