MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW OUS PI PICC KIT: 2-L 5.5FR X 55CM CG+; CATHETER,INTRAVASCULAR,THERAP

Model Number IPN920814

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Perforation of Vessels (2135)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: picc was inserted on tuesday (b)(6) 2023 in the operating theatre for post-op tpn.Picc was not trimmed.The line was placed by anaesthetic registrar, directly supervised by anaesthetic consultant under ultrasound guidance on the first pass with no problems using a modified seldinger technique.It was reported one lumen was bleeding back and flushing fine and the other one wasn't bleeding back.The catheter was secured with statlock, 17cm exposed.The location was confirmed by chest x-ray and line released to be used.Patient received parenteral nutrition via picc at 20ml/hr, increased to 50ml/hr and finally 70ml/hr.On thursday, (b)(6) 2023, patient was found to be in respiratory distress and admitted to icu.Ctpa was ordered to rule out pulmonary embolus (pe).There was no pe but ct showed bilateral pleural effusions which were drained on friday (b)(6) 2023.Pleural effusions were milky white in color.Radiologist was re-consulted.Ct images were relooked at and then found that the tip perforated the left bracho-cephalic vein.Tip was lying 3 cm outside the left brachiocephalic vein.Clinical consequences: patient became critically ill, required icu support and transfer to a specialist hospital.1 liter was drained from each pleural cavity.Patient was intubated and transferred to another hospital for removal of picc line under thoraco-vascular team and interventional radiology.It was reported the patient has been recently discharged home and recuperating.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo showing an x-ray image for analysis.No definitive conclusions about the device performance or the patient outcome could be determined from the supplied photo.A complete visual inspection of the device could not be performed as no sample was returned for analysis.A device history record review was performed, and a potentially relevant finding was identified.It was determined that this finding is not relevant to the failure mode involved with this complaint.The ifu provided with the kit informs the user, "clinicians must be aware of complications/undesirable side-effects associated with piccs including, but not limited to: cardiac tamponade secondary to vessel, atrial, or ventricular perforation; air embolism; catheter embolism; catheter occlusion; bacteremia; septicemia; extravasation; thrombophlebitis; thrombosis; inadvertent arterial puncture; nerve injury/damage; hematoma; bleeding/hemorrhage; fibrin sheath formation; exit site infection; vessel erosion; catheter tip malposition; dysrhythmias; svc syndrome; phlebitis; and anaphylaxis".The customer report of a catheter tip damaged the tissue of a vessel was not able to be confirmed through evaluation of the available information.The customer provided one x-ray image, however, no definitive conclusions about the device performance or the patient outcome could be determined from the photo.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related cause.Based on the available information, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: picc was inserted on tuesday (b)(6) 2023 in the operating theatre for post-op tpn.Picc was not trimmed.The line was placed by anaesthetic registrar, directly supervised by anaesthetic consultant under ultrasound guidance on the first pass with no problems using a modified seldinger technique.It was reported one lumen was bleeding back and flushing fine and the other one wasn't bleeding back.The catheter was secured with statlock, 17cm exposed.The location was confirmed by chest x-ray and line released to be used.Patient received parenteral nutrition via picc at 20ml/hr, increased to 50ml/hr and finally 70ml/hr.On thursday, (b)(6) 2023, patient was found to be in respiratory distress and admitted to icu.Ctpa was ordered to rule out pulmonary embolus (pe).There was no pe but ct showed bilateral pleural effusions which were drained on friday (b)(6) 2023.Pleural effusions were milky white in color.Radiologist was re-consulted.Ct images were relooked at and then found that the tip perforated the left bracho-cephalic vein.Tip was lying 3 cm outside the left brachiocephalic vein.Clinical consequences: patient became critically ill, required icu support and transfer to a specialist hospital.1 liter was drained from each pleural cavity.Patient was intubated and transferred to another hospital for removal of picc line under thoraco-vascular team and interventional radiology.It was reported the patient has been recently discharged home and recuperating.

• Brand Name: ARROW OUS PI PICC KIT: 2-L 5.5FR X 55CM CG+
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16752032
• MDR Text Key: 313421538
• Report Number: 9680794-2023-00260
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 20801902198079
• UDI-Public: 20801902198079
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: IPN920814
• Device Catalogue Number: CDA-45552-HPK1A
• Device Lot Number: 13F22F0498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TOTAL PARENTERAL NUTRITION (TPN); TOTAL PARENTERAL NUTRITION (TPN)
• Patient Outcome(s): Required Intervention; Hospitalization