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

Catalog Number	7266V
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the micro introducer hub was separated from sheath.The patient went to interventional radiologist (ir) so that the sheath could be retrieved.The ir used a snare to remove the sheath from the patient.The patient was fine and had no complications.As per the additional information reported, the procedure performed was an ablation procedure through a venous femoral access site.The access was obtained via ultrasound and there were no issues in gaining access to the vessel with the micro introducer kit.The sheath was inserted with higher-than-normal sheer pressure due to the large patient pannus.There was no heavy calcification or scar tissue and there was no vessel injury from sheath separation.
Event or Problem Description
It was reported that the micro introducer hub was separated from sheath.The patient went to interventional radiologist (ir) so that the sheath could be retrieved.The ir used a snare to remove the sheath from the patient.The patient was fine and had no complications.As per the additional information reported, the procedure performed was an ablation procedure through a venous femoral access site.The access was obtained via ultrasound and there were no issues in gaining access to the vessel with the micro introducer kit.The sheath was inserted with higher-than-normal sheer pressure due to the large patient pannus.There was no heavy calcification or scar tissue and there was no vessel injury from sheath separation.
Additional Manufacturer Narrative
(b)(4).One-unit of mik hub, dilator and guidewire were returned to teleflex for evaluation.Blood particulates were noted on the units.No shaft lumen was observed on the hub.The separation appears to be a clean break from the hub.Unit was manufactured at tecate.A dhr review was completed.No issues or nonconformances were noted for the lot.One-unit of mik hub, dilator and guidewire were returned to teleflex for evaluation.No shaft lumen was observed on the hub.The separation appears to be a clean break from the hub.A picture was sent by the customer confirming removal of the shaft lumen.Additional information was requested.A response was received.Access was gained with ultrasound without any issues.The body habitus was an influential factor.Disproportionate amount of weight was distributed in the pannus.The sheath was subjected to more sheer pressure than nominal as the pannus was very mobile.No vessel injury noted.There was no heavy calcification or scar tissue.Based on the product evaluation, the shaft is likely not bonded correctly to the hub.Tecate was notified of the complaint and it is for further investigation, lot review and other testing.

• Brand Name: VSI MICRO-INTRODUCER KITS
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17603608
• Report Number: 2134812-2023-00038
• Device Sequence Number: 6162333
• Product Code: DYB
• UDI-Device Identifier: 10841156107086
• UDI-Public: 10841156107086
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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 Expiration Date: 03/14/2026
• Device Catalogue Number: 7266V
• Device Lot Number: 73D2300575
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 150 KG