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

Model Number	G34521
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Thrombus (2101)
Date of Event	09/24/2018
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.
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.A document based investigation was conducted including a review of complaint history, the device history record, drawings, instructions for use, and quality control data.There is no information regarding the selection of this catheter sizes.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 tendencies to promote clots.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).The patient was a recent amputee and although it states patient was independent with crutches, it is not known how long before patient reached this level of independence.The patient was receiving some postoperative intervention august 10 but the picc was inserted in september for antibiotic therapy.It is not known if the antibiotic therapy was related to the surgical procedure and if patient was less active during the period of antibiotic therapy.In addition, it might be feasible to suggest that the recent use of crutches could have caused some irritation around the picc line site.Thromboembolism (if not treated) could result in a pulmonary embolism and potentially cause critical harm.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.At this time, the clinical assessment cannot eliminate any possible causes for this event such as medical procedure, user technique, human anatomy/physiology, device maintenance, device handling, device failure, or manufacturing related causes.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.(b)(4).A review of the device history records for the final lot, 8901810, recorded no related non-conformances.The catheter subassembly component lot (ic8854287) and all three (3) contained catheter subassembly lots (sa8396120, sa8588301, sa8521142) recorded no non-conformances.A review of complaint history records revealed no other complaints have been reported for lot 8901810.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.Furthermore, the device was in place for approximately 1 month prior to the complications, suggesting that it was not procedure 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 clinical assessment stated that immobilization is a potential cause for dvt formation.The patient had a history of various medical conditions and was a recent amputee patient, suggesting that they are not highly mobile.Although they were reported to be mobile on crutches/wheelchair, it is unknown how often they are actually mobile or how long it took them to become mobile post-op.It is also possible that the use of crutches could have irritated the site of the device.The device was secured with a secur-a-cath device, but the use of the crutches could still have led to movement of the device.This could cause catheter tip displacement, which could cause irritation of the vessel walls, leading to thrombosis.A definitive conclusion could not be determined.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
Additional information provided on 05feb2019 via phone conversation.As stated, the additional information that we have requested can be inferred by patient diagnosis or is otherwise not available.It was confirmed that the secure-a-cath was used and if the secure-a-cath device was causing problems to the flow in the device, the pump would indicate so.The reporter also stated that she understands that patient morbidity may have played a factor in this case.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: b2 additional information: a2, a4, b3, b5, b7, d6, d7 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 or Problem Description
It was reported in additional information received on 11jan2019 that a patient had a cook 4.0fr turbo-ject® single lumen over-the-wire power-injectable picc placed on (b)(6) 2018 in the right arm for iv therapy.The catheter was 47cm in length with 3cm exposed, and was secured with a secur-a-cath device.Medications used in the lines included; vancomycin (initiated 01sep2018; discontinued 04sep2018), cefazolin sodium (initiated 09sep2018; discontinued 11sep2018); daptomycin (initiated 12sep2018; discontinued 24sep2018).When not in use, the picc was locked with normal saline and was flushed every 12 hours.The patient did not have history of thrombosis and did not receive anti-coagulation therapy upon insertion of the device.However, the patient received post operative vte prophylaxis that began on (b)(6) 2018 (dalteparin 5000 units subcutaneous, once daily).The patient was a new amputee whose mobility is described as independent with transfers using crutches or wheelchair.Twenty-two days after insertion, on 24sep2018, patient complained of arm pain.A doppler was completed on 24sep2018 and confirmed a deep vein thrombosis around picc insertion site and line.A diagnosis was made of an obstructing thrombus from the picc insertion site in the subclavian vein, and the picc line was then removed.Upon diagnosis of the deep vein thrombosis, enoxaparin, 1mg/kg subcutaneous daily was ordered until international normalized ratio (inr) was greater than 2.Also ordered was warfarin 5mg, by mouth at bedtime.Weight recorded on patient's medication administration record was 113.4kg.

• Brand Name: TURBO-JECT® SINGLE 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: 8184820
• Report Number: 1820334-2018-03696
• Device Sequence Number: 16508660
• Product Code: LJS
• UDI-Device Identifier: 00827002345218
• UDI-Public: (01)00827002345218(17)200522(10)8901810
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132334
• 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): 03/04/2019

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: 05/22/2020
• Device Model Number: G34521
• Device Catalogue Number: UPICS-4.0-CT-OTW-ST-1111
• Device Lot Number: 8901810
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/11/2019; 02/05/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/07/2019; 03/04/2019
• 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: 59 YR
• Patient Weight: 122