MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN037306

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Nausea (1970); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

Medwatch form received reports: "picc line insertion.Case proceeded normally until line was in superior vena cava.While positioning the last few cm, patient stated he was feeling nauseous.Patient felt the need to urinate.Patient then began having seizure like movements.Patient became unresponsive.Procedure aborted.Code blue called.Discovered to be an allergic reaction to the chlorehexidine.".

Event Description

Medwatch form received reports: "picc line insertion.Case proceeded normally until line was in superior vena cava.While positioning the last few cm, patient stated he was feeling nauseous.Patient felt the need to urinate.Patient then began having seizure like movements.Patient became unresponsive.Procedure aborted.Code blue called.Discovered to be an allergic reaction to the chlorehexidine." additional information received from the sales rep 25-apr-2023 indicates the patient has a complex medical history with several allergies.It was also reported that the code blue was called when the patient's heart rate changed, and the patient became unresponsive but never lost pulse.They needed to remove the catheter and treat the patient with levophed, epi, benadryl and oxygen.Shortly after removal of the line and treatment, the allergy-like symptoms resolved.The patient was transferred to the icu for just under 24 hours for observation.There was no injury to the patient and the current condition of the patient was reported as "fine".The patient was to follow up with an allergist to confirm the chg allergy; however, it was reported that the patient cancelled their last allergy test appointment with the clinic and will "follow up at a later date".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The customer report of an allergic reaction was not able to be confirmed by the event details of the reported complaint.The pressure injectable arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, however, it was not confirmed that the patient has a hypersensitivity to chlorhexidine.Based on the information available at this time, the root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 16620205
• MDR Text Key: 312103110
• Report Number: 9680794-2023-00224
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F22L0485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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: NOT REPORTED; VANCOMYCIN AND OPIOIDS
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male