MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC MICRO-INTORDUCER KIT; CATHETER

Model Number 7280V

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation has been opened to review history record and risk documentation.A follow up report will be submitted after investigation.

Event Description

It was reported that: ""vsi micro-intorducer was introduced into the rfa.Upon retrieval md noticed that only a small piece was retrieved.Remaining portion was left on wire, access was obtained on lfa using a 6f snare and snared wire on the right side, and pulled tip of j wire back through the left side.4f aqua-tempo inserted on rfa advanced over wire to push introducer out lfa"" additional information: patient didn't have any injuries from issue.Patient is doing fine.They were able to snare and retrieve product pieces.

Manufacturer Narrative

There was no returned product.Therefore, a returned product evaluation could not be completed.The event description states; micro-introducer was inserted into the right femoral artery (rfa).Upon retrieval physician noticed that only a small piece was retrieved.Remaining portion was left on the wire, access was obtained on left femoral artery (lfa) using a 6f snare and snared wire on the right side, and pulled tip of j wire back through the left side.4f diagnostic catheter inserted on rfa advanced over wire to push introducer out lfa.The procedure was completed and the patients current condition is reported as fine.Multiple attempts were made to obtain more information but no response was received.This is a supplied component.Supplier completed a device history record (dhr) and lot review and no nonconformances were found.Based on the lack of information received the root cause of the issue is undeterminable.

• Brand Name: MICRO-INTORDUCER KIT
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 6464 sycamore court north; minneapolis, MN 55369 ; 7366564300
• MDR Report Key: 15526780
• MDR Text Key: 301009128
• Report Number: 2134812-2022-00054
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7280V
• Device Lot Number: 73B8800608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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