MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VSI MI,4FST,40CM,SS/SS,7ECO; INTRODUCER, CATHETER

Catalog Number	7260V
Medical Device Problem Codes	Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported via medwatch "while getting access for pacemaker, microwire wrapped around wholey wire and got knotted while getting second access.We were trying to get it unknotted and the microwire broke.We had to call intervention radiologists to retrieve wire from patients left subclavian vein by snare from groin access".The patient's current condition is reported as "unknown" at this time.Additional information was requested from the customer, no additional information has been given at this time.
Additional Manufacturer Narrative
(b)(4).Correction to section h: udi number.Additional information: no return product evaluation could be completed as the device was not returned for investigation.It is unknown where the wire broke.A dhr review was completed, and no issues or non-conformities were noted.Case details were reviewed.The ifu states the following warnings and precautions: - 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 perforation.- do not withdraw the guidewire through the needle.If necessary, remove both the needle and guidewire as a unit to prevent the needle from damaging or shearing the guidewire.It is unknown if the wire was operated against resistance or wire was withdrawn through the needle.Based on the information, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar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
It was reported via medwatch "while getting access for pacemaker, microwire wrapped around wholey wire and got knotted while getting second access.We were trying to get it unknotted and the microwire broke.We had to call intervention radiologists to retrieve wire from patients left subclavian vein by snare from groin access".The patient's current condition is reported as "unknown" at this time.Additional information was requested from the customer, no additional information has been given at this time.

• Brand Name: VSI MI,4FST,40CM,SS/SS,7ECO
• 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: 20047834
• Report Number: 2134812-2024-00042
• Device Sequence Number: 15443702
• Product Code: DYB
• UDI-Device Identifier: 10841156106850
• UDI-Public: (01)10841156106850(11)240305(17)270314(10)73C2400407(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7260V
• Device Lot Number: 73C2400407
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: Black Or African American