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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Thrombus (2101)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 customer reported they received an anecdotal report of thrombus formation around the picc lines for seven different patients.This resulted in deep vein thrombosis (dvt).Additional patient and event details have been requested.The customer has advised they are seeking the details of these reports.At the time of this report, no further details have been forthcoming.The following reports are being filed to represent each of the indicated seven patients.Patient 1, manufacturer report # 1820334-2018-03696; patient 2, manufacturer report # 1820334-2018-03697; patient 3, manufacturer report # 1820334-2018-03698; patient 4, manufacturer report # 1820334-2018-03699; patient 5, manufacturer report # 1820334-2018-03700; patient 6, manufacturer report # 1820334-2018-03701; patient 7, manufacturer report # 1820334-2018-03702.
Event or Problem Description
It as reported in additional information received on 11jan2019 that the patient had a cook 5.0fr turbo-ject® double lumen over-the-wire power-injectable picc placed on (b)(6) 2018 in the left arm.The picc measured 55cm in length with 5cm exposed, and was secured with a secur-a-cath device.When the picc was not in use, it was flushed every 12 hours and then locked with normal saline.The patient had no prior history of thrombosis and was noted to be ambulating independently.Tizaparin 4500 units subcutaneous began on (b)(6)2018, and was then ordered to be increased to 7500 units subcutaneous on (b)(6) 2018.However, the first dose on the 10th was held, and was administered at this amount on (b)(6)2018.Iv therapy included; pantoprazole (initiated (b)(6) 2018, discontinued (b)(6) 2018) and total parenteral nutrition (tpn) (initiated (b)(6) 2018, discontinued (b)(6) 2018).Five days after device insertion, on (b)(6) 2018, a hyperechoic thrombus was discovered surrounding the picc.It did not extend into the patent axillary or subclavian veins.The tpn was discontinued and the picc was removed on (b)(6) 2018.Treatment for the hyperechoic thrombus included xarelto, 15mg, by mouth, twice daily for three weeks, followed by xarelto 20mg, by mouth, once daily, for three months.The patient was treated for the deep vein thrombosis with no further known complications.
Additional 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation the complaint device was not returned for an evaluation.There are no devices from the complaint lot (9088015)) remaining in stock at the north american distribution center (nadc) for evaluation.A document based investigation was conducted including a review of complaint history, the device history record, drawings, instructions for use, and quality control data.Venous thromboembolisms are related to many factors.Per a recent journal article discussing increased rates of dvt related are the increased insertion of central venous catheters (cvc), peripherally inserted central catheters (picc).Other factors considered to increase the risk of dvt-ue are ¿ immobilization, and a history of thromboembolic events.The formation of a dvt-ue seems to be particularly favored by the combination of irritation of the vessel wall by a cvc or by chemotherapeutics and tumor-related hypercoagulability of the blood.The second independent risk factor for dvt-ue is malignant disease.Surgical intervention is the third principal risk factor for dvt-ue.(heil, et al).We have not information regarding patient¿s hydration status even with tpn.Another recent article involving 121 patients discusses, ¿high cumulative incidence of svt was found in high-risk patients with cancer, recent surgery and parenteral nutrition, in spite of antithrombotic prophylaxis.¿ (berea-baltierra, et al.).This same article concluded, ¿high-osmolarity and high-protein nutrition formulas were shown to be risk factors for svt in cancer patients receiving tpn.¿ (berea-baltierra, et al.).Thromboembolism (if not treated) could result in a pulmonary embolism and potentially cause critical harm.It is not certain if any of the devices will be returned for evaluation.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.At this time, most probable cause of this event is disease progression related.Citations are from: heil, j., miesbach, w., vogl, t., o.Bechstein, w., & reinisch, a.(2017).Deep vein thrombosis of the upper extremity: a systematic review.Deutsches arzteblatt international, 114(14), 244¿249, http://doi.Org/10.3238/arztebl.2017.0244.Ricardo berea-baltierra, rodolfo rivas-ruiz, [.], and laura escobedo-hernandez (2014).Risk factors for subclavian vein thrombosis in cancer patients with total parenteral nutrition, j clin med res.2014;6(5):345-353, doi: 10.14740/jocmr1862w.A review of the device history records for the final lot, 9088015, recorded no non-conformances.The catheter subassembly component lot, ic9013164, and the contained catheter subassembly lot, sa8967856, recorded no non-conformances.A review of complaint history records revealed no other complaints have been reported for the complaint lot, 9088015.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings peripherally inserted central venous catheters play an important role in treatment of critically ill patients.However, catheter tips can erode or perforate vascular walls.Extreme caution must be used in placement and monitoring of catheters.Precautions select puncture site and length of catheter needed by assessing patient anatomy and condition.If lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Patient movement can cause catheter tip displacement.Catheter size should be as small as use will allow.Product recommendations catheter size and puncture site preliminary reports indicate that catheter size can influence clotting.Larger diameter catheters have more tendency to promote clots.As reported¿clot formation has less relation to type of catheter material than to size of catheter.The angle of the catheter tip to the vessel wall should be checked carefully.In order to guarantee extrapericardial location, the catheter tip should be located above the svc-ra junction, within the lower 1/3 of the svc.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 infusates.Catheter maintenance catheter entry site must be prepared and maintained in a manner consistent with standard procedure for central venous catheterization.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.Note: if microclave or other needleless adapters approved for saline only lock are used, saline only lock may be used.Catheter lock should be reestablished after every use or at least every 24 hours if unused.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.How supplied upon removal from package, inspect the product to ensure no damage has occurred.With the known information on the device itself, there is no evidence to suggest the failure mode was manufacturing related.The customer stated that the picc was locked with normal saline and flushed every 12 hours when not in use.There is no information on whether microclaves or needleless adapters were used, but they are required if a saline only lock is used, per the device ifu.The device was secured with a secur-a-cath device, movement of the device could still occur.This could cause catheter tip displacement, which could cause irritation of the vessel walls, leading to thrombosis.The patient had a history of hypertension, hypothyroidism, a laparoscopic sigmoid resection (for a malignant polyp), atrial fibrillation, and was a recently diagnosed diabetic prior to the insertion of the device.The patient was also receiving tpn.These conditions, particularly the malignancy and tpn, are considered risk factors for the development of dvt, so it is likely that they contributed to the failure.However, a definitive conclusion could not be determined there is no evidence to suggest the failure mode was manufacturing related.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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 or Problem Description
No new event information received since the last report.

• 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
• MDR Report Key: 8202755
• Report Number: 1820334-2018-03700
• Device Sequence Number: 334898
• Product Code: LJS
• UDI-Device Identifier: 00827002239050
• UDI-Public: (01)00827002239050(17)200811(10)9088015
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2019

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 Expiration Date: 08/11/2020
• Device Model Number: G23905
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1111
• Device Lot Number: 9088015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/11/2019; 02/13/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/07/2019; 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 89