MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-25703-E

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "patient to whom the right subclavian central venous catheter is advanced and when removing the metallic guide it is adhered to the vessel and does not come out, a chest x-ray is taken and it is evidenced rolled in the subclavian vein, the hemodynamics and surgeon are immediately informed." the patient was taken to "the hemodynamic room for a foreign body extraction procedure with the possibility of requiring surgical act and vascular examination for the removal of the guide and surgical vessel repair".The patient's current condition was reported to be fine.

Event Description

The complaint is reported as: "patient to whom the right subclavian central venous catheter is advanced and when removing the metallic guide it is adhered to the vessel and does not come out, a chest x-ray is taken and it is evidenced rolled in the subclavian vein, the hemodynamics and surgeon are immediately informed." the patient was taken to "the hemodynamic room for a foreign body extraction procedure with the possibility of requiring surgical act and vascular examination for the removal of the guide and surgical vessel repair".The patient's current condition was reported to be fine.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the actual device is not available for return; however, the customer did provide two photos for evaluation.The first photo displayed an unraveled guide wire exiting a patient.The second photo displayed an x-ray image showing the guide wire severely unraveled and tangled inside a patient.Although the customer report of an unraveled guide wire was confirmed, a full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit warns the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the customer report of an unraveled guide wire was confirmed by complaint investigation of the customer supplied photos.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11924969
• MDR Text Key: 255176455
• Report Number: 3006425876-2021-00495
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F20L0803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR