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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis (2100)
Date of Event	12/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the manufacturing instructions, quality control, and instructions for use (ifu) 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.A review of the device history record shows no nonconforming events which could contribute to this failure mode.Per clinical review: there is no medical history for review other than the patient has lupus erythematosus.Patients with systemic lupus erythematosus possess an increased risk for thrombosis due to many factors including antiphospholipid antibodies and the patient¿s inflammatory processes.A good reference is ¿thrombosis in systemic lupus erythematosus: a review article¿ (isrn rheumatology volume 2012 (2012), article id 428269, 6 pages, http://dx.Doi.Org/10.5402/2012/428269).A review of the rituximab medication guide (reference http://www.Rituxan.Com/) does not list clotting or thrombus as a side effect.At this time, the most likely cause of this event is disease progression related.Per the instructions for use (ifu) "catheter size should be as small as the use will allow.-preliminary reports indicate that catheter size can influence clotting.Larger diameter catheters have more tendency to promote clots." 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 includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that following the removal of the turbo-ject® single lumen power-injectable picc (peripherally inserted central catheter), the patient later reported pain in their breast on the weekend of (b)(6) 2017 and (b)(6) 2017.The following weekend of (b)(6) 2017 and (b)(6) 2017, the patient arrived in the emergency room with predominant cervicalgia on the right radiating up to the clavicular medio right, and suspected deep vein thrombosis of the superior vena cava system.This suspicion was confirmed via angioscanner.Deep vein thrombosis of right axillary vein, right subclavian vein, right venous trunk, superior vena cava and right internal jugular vein without cerebral thrombophlebitis were confirmed.The patient reportedly had developed multiple collaterals on the right side.The patient also exhibited permeability of the left venous network, and was febrile (fever without point of call).The patient was subsequently hospitalized for monitoring as well as for the initiation of curative anticoagulation.The patient had originally been treated for systemic lupus erythematosus by rituximab.Day 1 of the treatment was (b)(6) 2017, and day 15 of the treatment was (b)(6) 2017.The complaint device is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.It should be noted there were no other reported complaints for this lot number.

• Brand Name: TURBO-JECT® SINGLE LUMEN 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
• MDR Report Key: 7234605
• Report Number: 1820334-2018-00184
• Device Sequence Number: 980713
• Product Code: LJS
• UDI-Device Identifier: 00827002238978
• UDI-Public: (01)00827002238978(17)190821(10)8159641
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-5.0-CT-NT-1111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/31/2018; 02/28/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 02/27/2018; 03/09/2018
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: PAIN (1994)
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RITUXIMAB; RITUXIMAB
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention