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

Model Number 7267X

Device Problem Material Frayed (1262)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

An investigation has been opened to review device history record and risk documentation.A follow-up report will be submitted upon completion of the investigation.

Event Description

As reported: the physician used a micro puncture kit (mik) for internal jugular (ij) access, the wire got curled up, so she pulled it out and it sheared coming back out of the needle.I was not present during this incident.The radiology technician was there and explained what happened and saved the mik to return for investigation.Additional information received on 23may2022: no part of the guidewire that was sheared was left behind in the vessel.

Manufacturer Narrative

One-unit of mik guidewire was returned for evaluation.Blood particulates were noted on the unit.The wire was stuck within the needle.The coil was unraveled.The unit was removed from the needle.There was no lot number provided for this complaint.Based on the sales distribution to the account, device history record review was requested for possible lots.No nonconformances were noted.Case details were reviewed.A 7267x unit was used for ij access.The wire got curled and got sheared when pulled out of the needle.One unit of mik introducer guidewire was returned for evaluation.The guidewire was locked within the needle.The wire was detached from the needle.Coil was observed to be unraveled from the core wire.Per ifu the following was noted: never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the guidewire against resistance may result in separation of the guidewire tip, damage to the guidewire, or vessel perforation.Do not withdraw the guidewire through the needle.If necessary, remove both the needle and guidewire as a unit to prevent the needle from damaging or shearing the guidewire.Additional information was requested from the account.A response was received.No part of the guidewire was left behind.Lot number is unavailable.No response was received on questions pertaining to procedural use and anatomical factors.No fluoroscopic images or videos of the issue were shared.It is likely that the operator withdrew the wire through the needle leading to the interaction between the bevel and the wire shaft causing it to unravel.A manufacturing record review was completed by heraeus on potential lots possibly shipped to the account.No related non-conformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: MICRO-INTRODUCER 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: angela meister ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564253
• MDR Report Key: 14632046
• MDR Text Key: 293553925
• Report Number: 2134812-2022-00034
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7267X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention