MAUDE Adverse Event Report: COOK INC UNKNOWN; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Catalog Number UNKNOWN

Device Problem Knotted (1340)

Patient Problem Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

The article referenced a "4 french turbo picc, 38 cm long".The assumed product code is upics-4.0-ct-40nt-1111.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

A journal article was reviewed, "unexpected obstacle in catheter removal could be due to knots spontaneously forming in peripherally inserted central catheters (picc)" which discussed the concern of spontaneously formed knots in picc lines could impair catheter removal.The author reported "peripherally central venous catheters (piccs) are widely used safe catheters, with a low rate of complications such as pneumothorax, hemothorax and hematoma.Complications are almost nil if piccs are positioned using a twin ultrasound and ecg technique standard procedure (1-3).This approach permits both safe vein cannulation and safe intraoperative check of catheter tip progression during placement.If the catheter placement is safe, the same cannot be said for the care of the device itself.We recently came across, on the day of discharge, a case of a three-knotted picc in the right basilica vein of an (b)(6) female, admitted to the hospital for community-acquired pneumonia (cap).Insertion of the 4 french turbo picc, 38 cm long (cook (b)(4)), was guided by ultrasound and the catheter tip position was intraoperatively checked with the ecg technique (using a standard alligator clam and a certodyne universal adapter, b-braun, (b)(4)), establishing its position at the superior vena cava-right atrial junction as confirmed by a standard chest x-ray.The chest x-ray did not show any knots or kinks at the tip.During the patient¿s hospitalization the picc was used as normal by nurses to infuse antibiotics and collect blood samples; no problems during the infusion and aspiration procedure were reported.The decision to remove the catheter was taken after 11 days of hospitalization.As usual a nurse removed the sutureless device ensuring the picc at the upper arm and began to slip off the picc.The picc moved 24 cm and then abruptly stopped; the nurse detected a resistance in the procedure, and the patient experienced pain at the insertion site.The physician in charge of the patient ordered a standard chest x-ray that showed the picc with three knots in the vessel portion of the catheter (fig.1).Every effort to force the dissolution of the knots with repeated flushes of saline solution was useless.Finally, a vascular surgeon surgically removed the knotted picc by exposure and suture of the basilica vein after local anesthesia and sedation (fig.2).The patient was discharged the next day without any further problems.Piccs have been proposed as an alternative to standard central venous catheters (cvcs) for both inpatients and outpatients for medium-term infusion therapy.They are non-tunneled vascular devices that can be inserted at the bedside by nurses and physicians (4).Piccs are safe well-known devices; however, some complications have been reported, such as catheter fracture, tip migration and accidental cuts near the hub (5).Recently, a high rate of thrombosis has been associated with these devices, if compared to standard cvcs in post-critically ill patients (4).Our experience suggests that when a picc does not work perfectly, not only in aspiration but also in infusion, a differential diagnosis with thrombosis must be considered, not forgetting the possibility of the catheter kinking or knotting.In the above-mentioned case, the picc could have been knotted both in the final days of the patient¿s hospitalization and during catheter removal; since drug infusion and patient hydration had been regular in the preceding days, the formation of knots could be due to removal maneuvers.A standard chest x-ray can help to visualize the catheter run and to demonstrate possible stops if the arm with the catheter is included in the x-ray plate.In conclusion, a spontaneously formed knot in a picc could impair catheter removal; therefore, not only safe placement but also safe catheter maintenance must be kept in mind.

Manufacturer Narrative

Method code: (4114) device not returned, results code: 3211 deformation problem, conclusion code: 4315 cause not established.Investigation: evaluation: a review of the instructions for use (ifu) and quality control was conducted during the investigation as well as a review photographic images provided in the complaint literature.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed which included images of the complaint device.There is no evidence to suggest the product was not made to specifications or that nonconforming devices are in house or in the field.Instructions for use for related devices state to inspect the device for damage upon removal from the package.The lot number of the device is not known; accordingly, a review of the complaint history and device history record could not be conducted.A clinical review of the article states further, ¿in the above-mentioned case, the picc could have been knotted both in the final days of the patient¿s hospitalization and during catheter removal; since drug infusion and patient hydration had been regular in the preceding days, the formation of knots could be due to removal maneuvers.A standard chest x-ray can help to visualize the catheter run and to demonstrate possible stops if the arm with the catheter is included in the x-ray plate.In conclusion, a spontaneously formed knot in a picc could impair catheter removal; therefore, not only safe placement but also safe catheter maintenance must be kept in mind.¿ there is no information regarding device maintenance and flushing.Per standard practice, picc lines and central lines should be flushed daily when not in use.It is feasible to suggest if routine flushing were performed the device would not be able to be flushed the last couple of days if knotted.The article suggests it may have knotted during withdrawal.Furthermore there were three knots.Based on current information the most probable cause of this event is medical procedure related.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.As reported in the article, there was no difficulty experienced placing or using the catheter.The knot was discovered after the device was difficult to remove.It is possible that the anatomy of the patient contributed to this event, however this could not be determined with certainty.Appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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: UNKNOWN
• Type of Device: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7659155
• MDR Text Key: 113054102
• Report Number: 1820334-2018-01891
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K132334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR