MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. VSI MICRO-INTRODUCER KIT; INTRODUCER, CATHETER

Model Number 7256V

Device Problems Difficult to Remove (1528); Unexpected Therapeutic Results (1631)

Patient Problems Laceration(s) (1946); Pain (1994); Foreign Body In Patient (2687)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

Pt is an adult female admitted with acute coronary syndrome and multivessel coronary artery disease.Not a candidate for coronary artery bypass grafting due to aortic calcification.History of bilateral carotid stenosis.I was called to the cath lab at the start of percutaneous coronary intervention by dr.The micropuncture wire was retained overlying or perhaps within the left common femoral artery (cfa), and appeared to tangle within the knot overlying the left cfa.I was unsuccessful in removing the wire.Under us guidance i accessed the midportion of the cfa.Dr.Then proceeded to place coronary stents.This evening post procedure pt reports left groin and back pain.Patient to or next day for removal of the micro puncture wire which was successful.The micropuncture wire was knotted within the common femoral artery connective tissue sheath.This was successfully removed without complication.

Event Description

Pt is an adult female admitted with acute coronary syndrome and multivessel coronary artery disease.Not a candidate for coronary artery bypass grafting due to aortic calcification.History of bilateral carotid stenosis.I was called to the cath lab at the start of percutaneous coronary intervention by dr.The micropuncture wire was retained overlying or perhaps within the left common femoral artery (cfa), and appeared to tangle within the knot overlying the left cfa.I was unsuccessful in removing the wire.Under us guidance i accessed the midportion of the cfa.Dr.Then proceeded to place coronary stents.This evening post procedure pt reports left groin and back pain.Patient to or next day for removal of the micro puncture wire which was successful.The micropuncture wire was knotted within the common femoral artery connective tissue sheath.This was successfully removed without complication.

• Brand Name: VSI MICRO-INTRODUCER KIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; maple grove MN 55369
• MDR Report Key: 13598867
• MDR Text Key: 286120617
• Report Number: 13598867
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2022,01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7256V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22995 DA
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: American Indian Or Alaskan Native