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

Model Number	7208V
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record were reviewed, preliminary there were no nonconformance related to this lot.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: had a complication involving a micro-introducer.The sheath broke off at the hub and slid down into the right external iliac vein.Had to terminate the ep procedure and a vascular surgeon had to take the patient to the or and do a cutdown to get the remaining part of the sheath out of the patient.Patient recovered well after cutdown procedure.
Event or Problem Description
Medsun report uf/importer report# 1300060000-2020-8021 recieved on 07jan2021.Describe the event or problem: obtaining femoral venous access in the ep lab per protocol with vsi micro-introducer kit (ref# (b)(4); loti675840).While technician was exchanging micro wire for larger wire the micro sheath broke at the hub, leaving about 7cm of the micro sheath in the pt's vein and/or subcutaneous tissue.An attempt was made by provider to grab the sheath with hemostats but he was unable to retrieve it.Dr.Arrives to attempt to remove the sheath after cutting down the skin.He was unsuccessful in doing so.He is now going to move the patient to the or to perform a deeper cut down to remove the sheath.Prior to ablation being performed a small sheath broke, such that the major length of the sheath was in the right external iliac vein.Attempts to remove the sheath by exploring subcutaneously were unsuccessful and fluoroscopy of the sheath demonstrated movement with the cardiac cycle suggesting an intravascular location.The patient subsequently underwent right external iliac venous dissection and venotomy with retrieval of the sheath by dr.The patient was monitored overnight and has remained hemodynamically stable.The patient will be discharged home in stable condition with plans to follow up with dr.To reschedule her ablation at a later time.Dr.Will arrange post-operative wound follow-up within 2 weeks.
Additional Manufacturer Narrative
One unit of mik was returned for investigation.A returned product evaluation was completed and sheath separation from the hub was confirmed.The failure noted on the returned unit is likely due to manufacturing/process deficiency.The probable cause is the sheath tubing was not seated in the correct position on the core pin by the manufacturing assembler during hub molding.An internal corrective action has been issued and closed to address this issue.

• Brand Name: MICRO-INTRODUCER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11010748
• Report Number: 2134812-2020-00098
• Device Sequence Number: 11886357
• Product Code: DYB
• UDI-Device Identifier: 10841156102685
• UDI-Public: (01)10841156102685
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: 7208V
• Device Catalogue Number: 7208V
• Device Lot Number: 675840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 59