MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,4FST,40CM,NIT/TUN7ECO; INTRODUCER, CATHETER

Catalog Number	7266V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dr reported that: " upon removal of introducer sheath the device separated from the hub." ai received on (b)(6) 2024: "shaft of sheath was removed in its entirety from the patient.There was no patient harm, injury or health consequences reported." associated complaints: 2134812-2024-00014 and 2134812-2024-00013.
Additional Manufacturer Narrative
(b)(4).No product evaluation could be completed as no product was returned for the investigation.A device record review could not be completed as a lot number was not provided.Case details were reviewed.Customer stated, "upon removal of introducer sheath the device separated from the hub." it is unknown to what extent of damages, if any, were present at the proximal end of the sheath near the hub.As per the additional information, the procedure was a tavr.Access site and vessel factors such calcification, scar tissue or tortuosity is unknown.Shaft of the sheath was removed.It is unknown if additional interventional procedure such as a snare was used to remove the sheath or if it was directly pulled off the wire.A manufacturing record could not be completed as the lot number is unknown.Based on the limited information, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.
Event or Problem Description
Dr reported that: " upon removal of introducer sheath the device separated from the hub." ai received on 20mar2024: "shaft of sheath was removed in its entirety from the patient.There was no patient harm, injury or health consequences reported." associated complaints: 2134812-2024-00014, 2134812-2024-00013 and 2134812-2024-00015.

• Brand Name: MI,4FST,40CM,NIT/TUN7ECO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19077347
• Report Number: 2134812-2024-00015
• Device Sequence Number: 14960082
• Product Code: DYB
• UDI-Device Identifier: 10841156102913
• UDI-Public: 10841156102913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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 Catalogue Number: 7266V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown