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	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: (b)(6) 2021.Customer (person): (b)(6).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 the hub of a turbo-ject® single lumen over-the-wire power-injectable picc was leaking and/or separated.As a result, the device was removed and replaced.The device was placed in the patient's right arm for administration of medication.No other adverse effects to the patient have been reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: ziekenhuisgroep twente (netherlands) informed cook on 27sep2021 of a hub issue from a upics-5.0-ct-otw-st-1111 (turbo-ject® single lumen over-the-wire power-injectable picc) from lot 13952907.The customer stated the hub was leaking and/or separated from the picc line.The device was removed and replaced and the patient did not experience any other adverse effects.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The customer did not return the device for evaluation.A device failure analysis could not be completed.However, a document-based investigation evaluation was performed.Cook reviewed the device master record for upics-5.0-ct-otw-st-1111.There are appropriate controls in place to detect damage prior to distribution.Cook also reviewed the device history record.There were no related complaints for lot 13952907.There were also no related nonconformances for lot 13952907, ic13822033 (catheter with rattlesnake holder), or lot sa13838914 (catheter).Cook reviewed product labeling.There are sufficient controls in place to detect damage prior to distribution.Cook also reviewed product labeling.The product ifu ¿turbo-ject over-the-wire peripherally inserted central venous catheters¿ provides the following information to the user related to the reported failure mode: warnings ¿the safe and effective use of turbo-ject picc lines with power injector pressures set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.To safely use turbo-ject picc lines with a power injector, the technician/health care professional must verify: the catheter lumen has ¿ct¿ on the hub to indicate the lumen is power injectable.Prior to use that the maximum pressure limit is set at or below 325 psi and that the maximum flow rate is at or below that which is listed on the catheter.Dynamic and statis pressure test results are shown in the following table.[5fr single hub has a 1.00 ml priming volume, 7ml/sec labeled flow rate, 125 psi maximum flow, 258 psi 37 degrees celsius average static burst water pressure, 250-266 psi 37 degrees celsius range static burst pressure.] *maximum flow rate pressures are determined with pump safety cut-off set at 325 psi, using contrast media with a viscosity of 11.8 cp.**static burst pressure is the failure point of the catheter when totally occluded.Warning: power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.Precautions if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Patient movement can case catheter tip displacement.Catheters places via an antecubital vein have shown tip movement of up to 10 cm with motion of the extremity.Catheter size should be as small as the use will allow.Instructions for use remove the access wire guide.Using fluoroscopic control, insert the loner marked wire guide to determine the correct catheter length by advancing the wire guide to the desired catheter tip location.Once the wire guide tip is in proper position, using the proximal portion of the wire guide that is external to the patient, measure the distance from the triple etch marks to puncture site.(the distal 60 cm of the wire guide is marked in 5 cm increments, with the triple etch marks positioned proximally at 60 cm.) trim catheter to the appropriate length (60 cm minus x measured cm).Catheters are available in various untrimmed lengths.Leaving the sheath and wire guide in place, remove the dilator by rotating the locking collar counterclockwise.Note: to prevent inadvertent air aspiration after removal of dilator, place thumb and finger around wire guide at the proximal end of the sheath.Introduce the catheter over the wire guide into the sheath as far as possible.Peel the sheath away from the catheter by grasping the two tabs of the sheath, snapping them down, and pulling outward and upward.Note: be sure to maintain stable catheter position while peeling sheath away.Once the sheath is removed, advance the catheter over the wire into final position.Remove the wire guide, secure the catheter to the skin, and dress in standard fashion.Verify catheter tip position using radiography or appropriate technology.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.Power injection procedure: 1.Use only lumens marked ¿ct¿ for power injection of contrast media.Warning: use of lumens not marked ¿ct¿ for power injection may result in catheter failure.2.Confirm proper catheter tip position radiographically prior to injection.3.Remove any injection/needleless caps from the turbo-ject picc.4.Attach a 10 ml (or larger) syringe filled with sterile normal saline to the hub of the extension tube to be used for power injection.5.Ensure adequate blood return and flush catheter thoroughly with the entire 10 ml of sterile normal saline to ensure lumen patency.Warning: failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.6.Remove syringe and attach power injection device to the catheter using the manufacturer¿s recommendations: 7.Conduct study using the power injector, making sure not to exceed the maximum flow rate or pressure limit for the catheter.8.Disconnect the power injection device and flush the catheter again with 10 ml of sterile normal saline.9.Place a new injection/needleless capon the turbo-ject picc, flush and lock catheter with saline or heparinized saline per institutional protocol.10.Confirm proper catheter tip position radiographically following power injection.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if packaging is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the device master record, device history record, product labeling, and design history file, there is no indication the device was manufactured out of specification.Based on the information provided, no product returned, and the results of the investigation, it was concluded the cause of this event is traced to device design.A capa was previously opened to investigate this failure mode.The capa investigation found that the root cause is related to inadequate flexural strength in a previous hub design change.Investigation further found that the devices were manufactured to specification and there was no evidence of lot-related issues.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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® 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
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12548181
• Report Number: 1820334-2021-02245
• Device Sequence Number: 5146642
• Product Code: LJS
• UDI-Device Identifier: 00827002239005
• UDI-Public: (01)00827002239005(17)230510(10)13952907
• Combination Product (Y/N): N
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: N/A
• Device Catalogue Number: UPICS-5.0-CT-OTW-ST-1111
• Device Lot Number: 13952907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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: ACCESS NEEDLE; SHEATH; WIRE GUIDE; ACCESS NEEDLE; SHEATH; WIRE GUIDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female