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

Catalog Number	7266V
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "during st-elevation myocardial infarction, patient was brought to cath lab, medical doctor accessed left groin, upon gaining access and putting in the 4f stiffen micro-introducer the sheath became dislodged into the patient's body.With assistance from vascular surgeon, the dislodged sheath was retrieved with snare." additional information has been requested from the account.
Event or Problem Description
It was reported that: "during st-elevation myocardial infarction, patient was brought to cath lab, medical doctor accessed left groin, upon gaining access and putting in the 4f stiffen micro-introducer the sheath became dislodged into the patient's body.With assistance from vascular surgeon, the dislodged sheath was retrieved with snare." additional information has been requested from the account.
Additional Manufacturer Narrative
Qn#(b)(4).No return product evaluation could be completed as the device was not returned for investigation.A dhr review was completed for lot 73m2300378, and no issues or nonconformities were noted.Case details were reviewed.Additional information could not be requested as the reporter elected to not be identified.Based on the information, the most likely root cause of the issue was undeterminable.The der process will continue to monitor for any similar events.Corrected data: correction to udi was updated from (b)(4) to include the full udi.

• 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: 19400700
• Report Number: 2134812-2024-00022
• Device Sequence Number: 8227206
• Product Code: DYB
• UDI-Device Identifier: 10841156102913
• UDI-Public: 10841156102913
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 7266V
• Device Lot Number: 73M2300378
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown