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

Model Number	G23905
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: no code available ¿ additional procedure required to replace picc line.Device code: device clogging is not labeled.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that a turbo-ject® double lumen over-the-wire power-injectable picc line clotted within two weeks of placement.After the nurse flushed the line, blood returned back from the picc line and was visible between the insertion site and end of line.A cook inc.Sales representative observed and reviewed their flushing technique and it is being done per label.It was noted the anesthesiologist believes the clotting is due to insufficient strength of the clamp; therefore, the line is not fully closing.The line was removed and new turbo-ject® double lumen over-the-wire power-injectable picc line was placed.To date, additional patient and event information have not been made available.This report is associated with medwatch 1820334-2018-01208 and medwatch 1820334-2018-01259.
Additional Manufacturer Narrative
Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, and trends of the device 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.There is no evidence to suggest the product was not made to specifications.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The ifu states, ¿preliminary reports indicate that catheter size can influence clotting.Larger diameter catheters have more tendency to promote clots.The catheter size should be as small as the use will allow.¿ based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We 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 or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Additional information: a2-a4: asku.B5: additional information was received on 18jul2018 stating the following: please provide date of event -not provided.Please provide patient demographics -not provided.What types of fluids were being infused through the line? chemotherapy.Please provide any images or videos of the device? line discarded already.What is the maintenance protocol of the complaint device? weekly flushing with 30mls saline then 5 mls heparin for flushing.No further information is available.H10: investigation evaluation.Clinical assessment: a recent journal article states, ¿risk factors of catheter-associated thrombosis can be categorized according to three types: catheter factors such as catheter size and type, tip location, insertion site, numbers of venous punctures, and catheter dwell time; patient-related factors such as malignancy, recent trauma or surgery, history of venous thromboembolism, older age, and renal failure; and medication factors such as chemotherapy, kinds of infusion liquids, and use of prophylactic anticoagulant.But the risk factors reported in different studies differ greatly¿ (et al liu y).Above citation comes from liu y, gao y, wei l, chen w, ma x, song l.Peripherally inserted central catheter thrombosis incidence and risk factors in cancer patients: a double-center prospective investigation.Therapeutics and clinical risk management.2015;11:153-160.Doi:10.2147/tcrm.S73379./gjs 22jun2018.The patient was on chemotherapy and per the previously mentioned article (et al liu) in the clinical assessment dated 10jul2018, chemotherapy is a risk factor for increased blood clots.Also, the frequency of chemotherapy is not known (daily, weekly, was patient on a rest period?).In addition, the customer stated maintenance protocol included ¿weekly flushing with 30mls saline then 5 mls heparin for flushing.¿ per ifu t_ctpiccotwtt, ¿catheter lock should be reestablished after every use or at least every 24 hours if unused.¿ at this time, the most probable causes of this event are medication, disease progression and/or device maintenance related.Additional information from the ifu: if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with a catheter locking solution.Catheter heparinization should be determined by institutional protocol and clinical judgment.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing catheter lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Conclusion: based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.However, per information received from the customer and the clinical assessment the infrequency of maintenance (flushing, etc.) to keep the line clear as instructed in the ifu can be considered a contributing factor.The customer is to receive a letter detailing the investigation findings.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 or Problem Description
See h10.
Additional Manufacturer Narrative
Correction: this report is being submitted retrospectively per fda request.The information in this report was previously submitted on 01aug2018 on a report with an incorrect follow up number 3.Therefore, this report is being submitted as a correction follow up number 2.Additional information: a2-a4: asku b5: additional information was received on 18jul2018 stating the following: please provide date of event -not provided please provide patient demographics -not provided what types of fluids were being infused through the line? chemotherapy please provide any images or videos of the device? line discarded already what is the maintenance protocol of the complaint device? weekly flushing with 30mls saline then 5 mls heparin for flushing no further information is available.H10: investigation evaluation clinical assessment: a recent journal article states, ¿risk factors of catheter-associated thrombosis can be categorized according to three types: catheter factors such as catheter size and type, tip location, insertion site, numbers of venous punctures, and catheter dwell time; patient-related factors such as malignancy, recent trauma or surgery, history of venous thromboembolism, older age, and renal failure; and medication factors such as chemotherapy, kinds of infusion liquids, and use of prophylactic anticoagulant.But the risk factors reported in different studies differ greatly¿ (et al liu y).Above citation comes from liu y, gao y, wei l, chen w, ma x, song l.Peripherally inserted central catheter thrombosis incidence and risk factors in cancer patients: a double-center prospective investigation.Therapeutics and clinical risk management.2015;11:153-160.Doi:10.2147/tcrm.S73379./gjs 22jun2018 the patient was on chemotherapy and per the previously mentioned article (et al liu) in the clinical assessment dated 10jul2018, chemotherapy is a risk factor for increased blood clots.Also, the frequency of chemotherapy is not known (daily, weekly, was patient on a rest period?).In addition, the customer stated maintenance protocol included ¿weekly flushing with 30mls saline then 5 mls heparin for flushing.¿ per ifu t_ctpiccotwtt, ¿catheter lock should be reestablished after every use or at least every 24 hours if unused.¿ at this time, the most probable causes of this event are medication, disease progression and/or device maintenance related.Additional information from the ifu: if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with a catheter locking solution.Catheter heparinization should be determined by institutional protocol and clinical judgment.Heparin concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing catheter lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Conclusion: based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.However, per information received from the customer and the clinical assessment the infrequency of maintenance (flushing, etc.) to keep the line clear as instructed in the ifu can be considered a contributing factor.The customer is to receive a letter detailing the investigation findings.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: TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7486150
• Report Number: 1820334-2018-01209
• Device Sequence Number: 1124333
• Product Code: LJS
• UDI-Device Identifier: 00827002239050
• UDI-Public: (01)00827002239050(17)180823(10)7221054
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G23905
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 07/18/2018; Not provided
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 07/16/2018; 09/24/2023; 08/01/2018
• Date Device Manufactured: 08/23/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE; SYRINGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown