MAUDE Adverse Event Report: COOK INC TURBO-JECT DOUBLE LUMEN POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Thrombosis (2100); No Code Available (3191)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer (person): (b)(6).Occupation: (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 reported that a turbo-ject® double lumen power-injectable picc had to be repositioned.The attending nurse inserted the catheter, but then the device had to be repositioned in the user facility's ir department.The patient had [a] deep vein thrombosis (dvt).The device was removed and replaced.Additional information regarding the patient, device, and event has been requested, however it was indicated by the customer that no additional information will be provided.

Manufacturer Narrative

Blank fields on this form indicate the information is 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

Clarification of the event was received on 19nov2020.The event was reported by a nurse at the user facility.Following device placement, a dvt was identified, resulting in the device being repositioned.The device was later removed and replaced.

Manufacturer Narrative

Investigation - evaluation.It was reported by st.Mary¿s general hospital, kitchener, ontario, canada that a patient had to have a picc line repositioned due to a deep vein thrombosis (dvt).The complaint device was reported to be a turbo-ject® double lumen power-injectable picc (rpn: (b)(4).A review of the instructions for use (ifu) and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One turbo-ject® double lumen power-injectable picc was retuned to cook for evaluation.Upon visual inspection, all joints were noted to be in tact and the tip was noted to be round.No deficiencies were discovered during the analysis.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 design history file (dhf) showed that this device 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.Given this 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 current ifu supplied with the device is t_ctpicctt_rev4.Pdf which includes the following: ¿precautions: -if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.-patient movement can cause catheter tip displacement.Catheters placed via an antecubital vein have shown tip movement of up to 10cm with movement of extremity catheter tip positioning.Verify catheter tip position using radiography or appropriate technology.In order to guarantee extrapericardial location, catheter tip should be located in the lower 1/3 of the svc and not beyond the extrapericardial cava.Every effort must be made to ascertain proper tip position in order to prevent erosion or perforation of the central venous system and to ensure proper delivery of infusated.Catheter maintenance: if blood is not freely aspirated, catheter tip position should be immediately reevaluated by physician.Catheter placement (fluoroscopic method).14.After the catheter is in final position, remove the obturator, secure the catheter to the skin and dress in a standard fashion.15.Verify catheter tip position using radiography or appropriate technology.In order to guarantee exrapericardial location, catheter tip should be located above the svc-ra junction, within the lower 1/3 of the svc.Catheter placement (non-fluoroscopic method).9.After the catheter is in final position, remove the obturator, secure the catheter to the skin and dress in a standard fashion.10.Verify catheter tip position using radiography or appropriate technology.In order to guarantee exrapericardial location, catheter tip should be located above the svc-ra junction, within the lower 1/3 of the svc.Power injection procedure: 2.Confirm proper catheter tip position radiographically prior to injection.10.Confirm proper catheter tip position radiograpically following power injection.¿ based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event could not be established.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 information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TURBO-JECT DOUBLE LUMEN POWER-INJECTABLE PICC
• 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: 10844097
• MDR Text Key: 216388187
• Report Number: 1820334-2020-02098
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K132885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-5.0-CT-NT-1111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention