MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC MI,5FST,40CM,NIT/TUN7ECO; INTRODUCER, CATHETER

Catalog Number	7267V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "micro introducer broke in half and the distal portion was stuck inside the patient's vein.A snare was used to remove it." additional information: "it was subclavian venous access for ppm lead placement.There was no calcification.".
Additional Manufacturer Narrative
Qn# (b)(4).Udi will be provided with the follow up report.
Additional Manufacturer Narrative
Qn#(b)(4).One unit of sheath separated as two pieces was returned for evaluation.Blood particulates were noted on sheath.The separated pieces were decontaminated and inspected.Minor polymer stretch was observed at the junction of the separation.Aside from the observed stretch, the polymer appears to be sliced as a clean cut along the circumference of lumen at an angle.A dhr review was completed for lot 73m2400565, and no issues or non-conformities were noted.Case details were reviewed.Damages are likely to have occurred during use when operated against resistance.The ifu states the following: 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 as per the additional information received, the procedure was a pacemaker insertion.The customer does perform a sub clavian cutdown technique at muscular level with percutaneous access.Blades and needles are used in the procedure.Customer did state that there is a possibility it was accidentally cut/damaged but felt as though the hub snapped off in his hand.Based on the observed damages on the sheath, it is likely that the operator accidently cut the lumen at an angle during access.A snare intervention was performed to retrieve the separated pieces.No patient harm noted.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.
Event or Problem Description
It was reported that: "micro introducer broke in half and the distal portion was stuck inside the patient's vein.A snare was used to remove it." additional information: "it was subclavian venous access for ppm lead placement.There was no calcification.".

• Brand Name: MI,5FST,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: 21812217
• Report Number: 2134812-2025-00011
• Device Sequence Number: 8990852
• Product Code: DYB
• UDI-Device Identifier: 10841156107079
• UDI-Public: (01)10841156107079(11)241218(17)271218(10)73M2400565(21)
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 03/21/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7267V
• Device Lot Number: 73M2400565
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 80 YR
• Patient Sex: Female