MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI MIDLINE 1-L: 4FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN056907

Device Problems Entrapment of Device (1212); Material Too Rigid or Stiff (1544)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: a localized superficial venous thrombosis formed in the basilic vein when the guide was being advanced under echo and got stuck, during use on the patient.They felt that the guide was very rigid.On removal there was no reported damage to the guide.There was no additional surgical intervention performed and no other symptoms.The patient was reported as stable throughout with no negative consequences other than increased procedure time.Associated to 3006425876-2023-00630 and 3006425876-2023-00629.

Manufacturer Narrative

Qn#(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.Without the device to evaluate the complaint could not be confirmed and 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

It was reported that: a localized superficial venous thrombosis formed in the basilic vein when the guide was being advanced under echo and got stuck, during use on the patient.They felt that the guide was very rigid.On removal there was no reported damage to the guide.There was no additional surgical intervention performed and no other symptoms.The patient was reported as stable throughout with no negative consequences other than increased procedure time.Associated to 3006425876-2023-00630 and 3006425876-2023-00629.

• Brand Name: PI MIDLINE 1-L: 4FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17286958
• MDR Text Key: 318698029
• Report Number: 3006425876-2023-00628
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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 Model Number: IPN056907
• Device Catalogue Number: EU-32041
• Device Lot Number: 71F23D0360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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; NOT REPORTED