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

Model Number 7266V

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.

Event Description

As reported: upon hand injection, sheath separated from hub leaving sheath in the body.Removed with cutdown to remove sheath.Patient is reported as doing well post procedure.

Manufacturer Narrative

One sheath from model 7266v was returned to vsi for evaluation.The shaft of the sheath was separated about 1-2mm from the hub.The separation point was stretched and torn.The separation was not related to seat depth of the shaft inside the hub.The damage to the shaft was at the separation was consistent with the sheath being pulled against resistance.This is evident by the stretched material.It is unknown if there was damage present to the shaft prior to injection.

• Brand Name: MICRO-INTRODUCER KIT
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10641626
• MDR Text Key: 210185246
• Report Number: 2134812-2020-00063
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 20841156102910
• UDI-Public: (01)20841156102910
• Combination Product (y/n): N
• PMA/PMN Number: K180913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 7266V
• Device Lot Number: 672999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 101